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  <front>
    <journal-meta>
      <journal-id journal-id-type="nlm-ta">Arq Bras Cardiol</journal-id>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id specific-use="scielo-v3" pub-id-type="publisher-id">Rk78fPjWrBtFKqT8J9YpSLf</article-id>
      <article-id specific-use="scielo-v2" pub-id-type="publisher-id">S0066-782X2022001000622</article-id>
      <article-id pub-id-type="publisher-id">abc.20210886</article-id>
      <article-id pub-id-type="doi">10.36660/abc.20210886</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Carta Cient&#237;fica</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Influ&#234;ncia do Bem-estar Espiritual na Press&#227;o Arterial, Hemodin&#226;mica Central e Fun&#231;&#227;o Endotelial</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-4785-9651</contrib-id>
          <name>
            <surname>Teixeira</surname>
            <given-names>Maria Em&#237;lia Figueiredo</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
          <xref ref-type="aff" rid="aff2">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-5487-4649</contrib-id>
          <name>
            <surname>Vitorino</surname>
            <given-names>Priscila Valverde de Oliveira</given-names>
          </name>
          <xref ref-type="aff" rid="aff3">
            <sup>3</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-7040-396X</contrib-id>
          <name>
            <surname>Brand&#227;o</surname>
            <given-names>Andrea A.</given-names>
          </name>
          <xref ref-type="aff" rid="aff4">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Souza</surname>
            <given-names>Ana Luiza Lima</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
          <xref ref-type="aff" rid="aff2">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Barbosa</surname>
            <given-names>Talles Marcelo Gon&#231;alves de Andrade</given-names>
          </name>
          <xref ref-type="aff" rid="aff5">
            <sup>5</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Esporcatte</surname>
            <given-names>Roberto</given-names>
          </name>
          <xref ref-type="aff" rid="aff4">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Borba</surname>
            <given-names>M&#225;rio Henrique Elesb&#227;o de</given-names>
          </name>
          <xref ref-type="aff" rid="aff6">
            <sup>6</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Avezum</surname>
            <given-names>&#193;lvaro</given-names>
          </name>
          <xref ref-type="aff" rid="aff7">
            <sup>7</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-1265-1930</contrib-id>
          <name>
            <surname>Barroso</surname>
            <given-names>Weimar Kunz Sebba</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label> 1 </label>
        <institution content-type="orgname">Universidade Federal de Goi&#225;s</institution>
        <institution content-type="orgdiv1">Liga de Hipertens&#227;o Arterial</institution>
        <addr-line>
          <named-content content-type="city">Goi&#226;nia</named-content>
          <named-content content-type="state">GO</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Universidade Federal de Goi&#225;s &#8211; Liga de Hipertens&#227;o Arterial , Goi&#226;nia , GO &#8211; Brasil </institution>
      </aff>
      <aff id="aff2">
        <label> 2 </label>
        <institution content-type="orgname">Universidade Federal de Goi&#225;s</institution>
        <institution content-type="orgdiv1">Programa de P&#243;s-Gradua&#231;&#227;o em Ci&#234;ncias da Sa&#250;de</institution>
        <addr-line>
          <named-content content-type="city">Goi&#226;nia</named-content>
          <named-content content-type="state">GO</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Universidade Federal de Goi&#225;s &#8211; Programa de P&#243;s-Gradua&#231;&#227;o em Ci&#234;ncias da Sa&#250;de , Goi&#226;nia , GO &#8211; Brasil </institution>
      </aff>
      <aff id="aff3">
        <label> 3 </label>
        <institution content-type="orgname">Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s</institution>
        <institution content-type="orgdiv1">Escola de Ci&#234;ncias Sociais e da Sa&#250;de</institution>
        <addr-line>
          <named-content content-type="city">Goi&#226;nia</named-content>
          <named-content content-type="state">GO</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s &#8211; Escola de Ci&#234;ncias Sociais e da Sa&#250;de , Goi&#226;nia , GO &#8211; Brasil </institution>
      </aff>
      <aff id="aff4">
        <label> 4 </label>
        <institution content-type="orgname">Universidade do Estado do Rio de Janeiro</institution>
        <institution content-type="orgdiv1">Departamento de Doen&#231;as do T&#243;rax</institution>
        <addr-line>
          <named-content content-type="city">Rio de Janeiro</named-content>
          <named-content content-type="state">RJ</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Universidade do Estado do Rio de Janeiro &#8211; Departamento de Doen&#231;as do T&#243;rax , Rio de Janeiro , RJ &#8211; Brasil </institution>
      </aff>
      <aff id="aff5">
        <label> 5 </label>
        <institution content-type="orgname">Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s</institution>
        <institution content-type="orgdiv1">Escola de Ci&#234;ncias Exatas e da Computa&#231;&#227;o</institution>
        <addr-line>
          <named-content content-type="city">Goi&#226;nia</named-content>
          <named-content content-type="state">GO</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s &#8211; Escola de Ci&#234;ncias Exatas e da Computa&#231;&#227;o (ECEC), Goi&#226;nia , GO &#8211; Brasil </institution>
      </aff>
      <aff id="aff6">
        <label> 6 </label>
        <institution content-type="orgname">Cardio Cl&#237;nica do Vale</institution>
        <addr-line>
          <named-content content-type="city">Lajeado</named-content>
          <named-content content-type="state">RS</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> Cardio Cl&#237;nica do Vale , Lajeado , RS &#8211; Brasil </institution>
      </aff>
      <aff id="aff7">
        <label> 7 </label>
        <institution content-type="orgdiv1">International Research Center</institution>
        <institution content-type="orgname">Hospital Alem&#227;o Oswaldo Cruz</institution>
        <addr-line>
          <named-content content-type="city">S&#227;o Paulo</named-content>
          <named-content content-type="state">SP</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original"> International Research Center , Hospital Alem&#227;o Oswaldo Cruz , S&#227;o Paulo , SP &#8211; Brasil </institution>
      </aff>
      <author-notes>
        <corresp id="c01">Correspond&#234;ncia: Maria Em&#237;lia Figueiredo Teixeira &#8226; Universidade Federal de Goi&#225;s &#8211; Liga de Hipertens&#227;o Arterial e Programa de P&#243;s-Gradua&#231;&#227;o em Ci&#234;ncias da Sa&#250;de &#8211; R. 235, s/n. CEP 74605-050, Setor Leste Universit&#225;rio, Goi&#226;nia, GO &#8211; Brasil E-mail: <email>emiliateixeiracardio@gmail.com</email> </corresp>
        <fn fn-type="con">
          <p>Contribui&#231;&#227;o dos autores</p>
          <p>Concep&#231;&#227;o e desenho da pesquisa: Teixeira MEF, Vitorino PVO, Brand&#227;o AA, Souza ALL, Barbosa TMGA, Esporcatte R, Borba MHE, Avezum A, Barroso WKS; An&#225;lise estat&#237;stica: Vitorino PVO; Reda&#231;&#227;o do manuscrito: Teixeira MEF; Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do intelectual importante: Vitorino PVO, Brand&#227;o AA, Souza ALL, Avezum A, Barroso WKS.</p>
        </fn>
        <fn fn-type="conflict">
          <p>Potencial conflito de interesse</p>
          <p>N&#227;o h&#225; conflito com o presente artigo</p>
        </fn>
      </author-notes>
      <pub-date date-type="pub" publication-format="electronic">
        <day>21</day>
        <month>10</month>
        <year>2022</year>
      </pub-date>
      <pub-date date-type="collection" publication-format="electronic">
        <month>10</month>
        <year>2022</year>
      </pub-date>
      <volume>119</volume>
      <issue>4</issue>
      <fpage>622</fpage>
      <lpage>626</lpage>
      <history>
        <date date-type="received">
          <day>05</day>
          <month>07</month>
          <year>2021</year>
        </date>
        <date date-type="rev-recd">
          <day>28</day>
          <month>01</month>
          <year>2022</year>
        </date>
        <date date-type="accepted">
          <day>16</day>
          <month>03</month>
          <year>2022</year>
        </date>
      </history>
      <permissions>
        <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/" xml:lang="en">
          <license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
        </license>
      </permissions>
      <kwd-group xml:lang="pt">
        <kwd>Espiritualidade</kwd>
        <kwd>Religi&#227;o e Medicina</kwd>
        <kwd>Press&#227;o Arterial</kwd>
        <kwd>Hemodin&#226;mica</kwd>
        <kwd>Endot&#233;lio/fisiologia</kwd>
        <kwd>Valores Sociais</kwd>
        <kwd>Valor da Vida</kwd>
        <kwd>Qualidade de Vida</kwd>
      </kwd-group>
      <counts>
        <fig-count count="0"/>
        <table-count count="2"/>
        <equation-count count="0"/>
        <ref-count count="34"/>
        <page-count count="5"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <disp-quote>
      <p>&#8220; <italic>Science is not only compatible with spirituality; it is a profound source of spirituality.</italic> &#8221;</p>
      <p>
        <bold>Carl Sagan</bold>
      </p>
    </disp-quote>
    <sec sec-type="intro">
      <title>Introdu&#231;&#227;o</title>
      <p>Espiritualidade <sup><xref ref-type="bibr" rid="B1">1</xref></sup> e religiosidade (E/R) s&#227;o aspectos culturais presentes desde os prim&#243;rdios da exist&#234;ncia humana. Vistas por muito tempo como opostas &#224; ci&#234;ncia, apenas recentemente, E/R ganharam relev&#226;ncia no &#226;mbito da sa&#250;de. <sup><xref ref-type="bibr" rid="B1">1</xref></sup></p>
      <p>As defini&#231;&#245;es de E/R est&#227;o em evolu&#231;&#227;o constante, de acordo com as necessidades de adequa&#231;&#227;o a novos conhecimentos. Religi&#227;o tem sido relacionada, contemporaneamente, com aspectos organizacionais, institucionais e dogm&#225;ticos, ou seja, o contato com a deidade acontece por meio de formatos pr&#233;-determinados e espec&#237;ficos para cada segmento religioso. <sup><xref ref-type="bibr" rid="B2">2</xref></sup> Espiritualidade, termo mais amplo, engloba a busca pelo bem-estar pessoal, psicol&#243;gico, espiritual e nas rela&#231;&#245;es pessoais. Para o Departamento de Estudos em Espiritualidade e Medicina Cardiovascular (DEMCA) da Sociedade Brasileira de Cardiologia (SBC), &#8220;espiritualidade &#233; um conjunto de valores morais, mentais e emocionais que norteiam pensamentos, comportamentos e atitudes nas circunst&#226;ncias da vida de relacionamento intra e interpessoal&#8221;. <sup><xref ref-type="bibr" rid="B3">3</xref></sup></p>
      <p>A hipertens&#227;o arterial (HA) &#233; doen&#231;a de elevada preval&#234;ncia e principal fator de risco para outras doen&#231;as cardiovasculares, <sup><xref ref-type="bibr" rid="B4">4</xref></sup> o que a torna a principal causa direta e indireta de mortalidade em todo o planeta. <sup><xref ref-type="bibr" rid="B5">5</xref></sup> Por ser uma doen&#231;a multifatorial, seu tratamento contempla medidas farmacol&#243;gicas e n&#227;o farmacol&#243;gicas, <sup><xref ref-type="bibr" rid="B6">6</xref></sup> que incluem medidas voltadas para o bem-estar f&#237;sico e mental. <sup><xref ref-type="bibr" rid="B7">7</xref> , <xref ref-type="bibr" rid="B8">8</xref></sup></p>
      <p>Pr&#225;ticas que busquem o bem-estar espiritual, aliadas ou n&#227;o &#224; religiosidade, tem sido relacionadas ao bom controle de muitas doen&#231;as, <sup><xref ref-type="bibr" rid="B9">9</xref></sup> al&#233;m de redu&#231;&#227;o de mortalidade em diversas situa&#231;&#245;es. <sup><xref ref-type="bibr" rid="B10">10</xref></sup> Existem evid&#234;ncias da associa&#231;&#227;o entre E/R e desfechos positivos em cardiologia, tais como Doen&#231;a Arterial Coronariana (DAC), <sup><xref ref-type="bibr" rid="B11">11</xref></sup> Insufici&#234;ncia Card&#237;aca (IC) <sup><xref ref-type="bibr" rid="B12">12</xref></sup> e HA. <sup><xref ref-type="bibr" rid="B13">13</xref> , <xref ref-type="bibr" rid="B14">14</xref></sup></p>
      <p>Estudos sobre E/R s&#227;o ainda incipientes, e a maioria observacionais. Em conjunto, E/R foram associadas a melhores h&#225;bitos de vida (menos sedentarismo, etilismo ou tabagismo), <sup><xref ref-type="bibr" rid="B15">15</xref></sup> menores valores press&#243;ricos, menor risco de HA <sup><xref ref-type="bibr" rid="B16">16</xref></sup> e melhor ades&#227;o terap&#234;utica. <sup><xref ref-type="bibr" rid="B17">17</xref></sup> Bem-estar espiritual isoladamente pode ser um fator cardioprotetor, por estar relacionado a menores n&#237;veis de press&#227;o arterial (PA), glicemia, triglic&#233;rides e LDL colesterol. <sup><xref ref-type="bibr" rid="B18">18</xref></sup> Por outro lado, um estudo observou maior probabilidade de HA associada &#224; maior frequ&#234;ncia de ora&#231;&#245;es, mas menor probabilidade de HA associada a vari&#225;veis de prop&#243;sito e perd&#227;o. <sup><xref ref-type="bibr" rid="B19">19</xref></sup></p>
      <p>Diante disso, torna-se relevante avaliar o efeito de uma interven&#231;&#227;o voltada para o bem-estar espiritual no controle press&#243;rico e de outros par&#226;metros hemodin&#226;micos. Este artigo descreve o m&#233;todo de um ensaio cl&#237;nico para avaliar uma interven&#231;&#227;o em espiritualidade sobre a PA perif&#233;rica e central (PAC), par&#226;metros de rigidez arterial e fun&#231;&#227;o endotelial, em hipertensos est&#225;gios 1 e 2 de baixo ou moderado risco cardiovascular antes e ap&#243;s 12 semanas de seguimento dentro de cada grupo (controle [GC] e interven&#231;&#227;o [GI]) e entre os grupos.</p>
    </sec>
    <sec sec-type="methods">
      <title>M&#233;todos</title>
      <sec>
        <title>Tipo e local do estudo</title>
        <p>Ensaio cl&#237;nico randomizado de n&#227;o inferioridade cuja coleta de dados ser&#225; realizada na Liga de Hipertens&#227;o Arterial da Universidade Federal de Goi&#225;s (UFG) e na Universidade do Estado do Rio de Janeiro. O protocolo ser&#225; devidamente cadastrado no Registro Brasileiro de Ensaios Cl&#237;nicos (ReBEC).</p>
      </sec>
      <sec>
        <title>Popula&#231;&#227;o, amostra e amostragem</title>
        <p>A popula&#231;&#227;o do estudo ser&#225; composta por adultos hipertensos (est&#225;gio 1 ou 2) com risco cardiovascular baixo e moderado, em uso est&#225;vel de medica&#231;&#227;o anti-hipertensiva h&#225; mais de trinta dias, avaliada por medidas press&#243;ricas da &#250;ltima consulta.</p>
        <p>A amostra foi calculada utilizando o OpenEpi. Foi considerada uma press&#227;o arterial sist&#243;lica (PAS) no GI de 130,9 &#177; 9,2 e no GC de 135,81 &#177; 9,3 mmHg, <sup><xref ref-type="bibr" rid="B20">20</xref></sup> com intervalo de confian&#231;a de 95% e poder de teste de 80% com 54 participantes em cada grupo.</p>
        <p>Ser&#227;o exclu&#237;dos hipertensos est&#225;gio 3 [PAS &#8805; 180 mmHg e/ou PA Diast&#243;lica (PAD) &#8805; 110 mmHg].</p>
        <p>Ap&#243;s a inclus&#227;o, ser&#227;o retirados aqueles que se recusarem a realizar qualquer procedimento e/ou apresentarem eleva&#231;&#227;o press&#243;rica durante o seguimento que impossibilite manter a conduta proposta sem altera&#231;&#227;o da medica&#231;&#227;o.</p>
      </sec>
      <sec>
        <title>Recrutamento e randomiza&#231;&#227;o dos pacientes do estudo</title>
        <p>As equipes envolvidas se reunir&#227;o para apresenta&#231;&#227;o, discuss&#227;o do projeto e treinamento para execu&#231;&#227;o rigorosa do protocolo e uniformiza&#231;&#227;o na abordagem aos pacientes, com vistas a garantir rigor metodol&#243;gico.</p>
        <p>Os pacientes ser&#227;o selecionados pelo &#250;ltimo registro da PA em prontu&#225;rio, verificando o est&#225;gio de HA e o risco cardiovascular em que se encontram e ser&#227;o convidados a participarem no estudo por meio de liga&#231;&#227;o telef&#244;nica. Aqueles que aceitarem participar, ser&#227;o chamados para a visita inicial.</p>
      </sec>
      <sec>
        <title>Visita inicial (V0)</title>
        <p>Os participantes ser&#227;o randomizados no site <italic>www.randomizer.</italic> org para um dos dois grupos.</p>
        <p>Todos receber&#227;o orienta&#231;&#245;es relacionadas a h&#225;bitos de vida saud&#225;veis e ser&#227;o submetidos &#224; anamnese, exame cl&#237;nico e entrevista para preenchimento de quatro question&#225;rios: Durel, <sup><xref ref-type="bibr" rid="B21">21</xref> , <xref ref-type="bibr" rid="B22">22</xref></sup> predisposi&#231;&#227;o ao perd&#227;o, <sup><xref ref-type="bibr" rid="B23">23</xref></sup> escala de gratid&#227;o <sup><xref ref-type="bibr" rid="B24">24</xref></sup> e escala de bem-estar espiritual. <sup><xref ref-type="bibr" rid="B25">25</xref></sup> Todo processo ser&#225; feito por pesquisadores previamente treinados, que utilizar&#227;o um roteiro padronizado, de forma a uniformizar a consulta e as orienta&#231;&#245;es.</p>
        <p>Al&#233;m disso, ser&#225; aferida PA casual por m&#233;todo oscilom&#233;trico com aparelho Dyna- MAPA AOP (Cardios, Brasil), que fornece valores de PA perif&#233;rica e central (PAC), velocidade de onda de pulso (VOP) obtida por algoritmo e equa&#231;&#227;o matem&#225;tica ARC SOLVER e expressa em metros/segundo, e Augmentation Index corrigido para 75% da frequ&#234;ncia card&#237;aca (AIx). <sup><xref ref-type="bibr" rid="B26">26</xref> , <xref ref-type="bibr" rid="B27">27</xref></sup> PA perif&#233;rica ser&#225; obtida conforme recomenda&#231;&#227;o da Diretriz Brasileira de HA 2020. <sup><xref ref-type="bibr" rid="B8">8</xref></sup></p>
        <p>A Monitoriza&#231;&#227;o Ambulatorial da Press&#227;o Arterial (MAPA) ser&#225; executada com aparelho Dyna-MAPA (Cardios, Brasil), seguindo as recomenda&#231;&#245;es da mais recente Diretriz Brasileira de MAPA. <sup><xref ref-type="bibr" rid="B28">28</xref></sup> A dilata&#231;&#227;o fluxo-mediada (DFM) ser&#225; realizada em aparelho de ultrassom de alta resolu&#231;&#227;o automatizado e com bra&#231;o rob&#243;tico para a precisa localiza&#231;&#227;o e medida da art&#233;ria braquial (UNEX EF 38G), de acordo com a t&#233;cnica de Celermajer et al., <sup><xref ref-type="bibr" rid="B29">29</xref></sup> preconizada pela International Brachial Artery Reactivity <italic>Task</italic> Force. <sup><xref ref-type="bibr" rid="B30">30</xref> , <xref ref-type="bibr" rid="B31">31</xref></sup> A DFM &#233; o atual padr&#227;o ouro para avaliar fun&#231;&#227;o endotelial; o endot&#233;lio saud&#225;vel apresenta FMD &gt; 10%, e valores abaixo a esse s&#227;o preditivos de maior risco cardiovascular. <sup><xref ref-type="bibr" rid="B32">32</xref></sup></p>
      </sec>
      <sec>
        <title>Visita intermedi&#225;ria (V1)</title>
        <p>A V1 ocorrer&#225; seis semanas ap&#243;s V0 por liga&#231;&#227;o telef&#244;nica para todos, com o intuito de avaliar o bem-estar individual e estimular o seguimento ativo na realiza&#231;&#227;o da interven&#231;&#227;o para aqueles do GI, esclarecendo a import&#226;ncia da execu&#231;&#227;o di&#225;ria da atividade proposta e o questionamento sobre poss&#237;veis fatores que possam limitar o acesso ou a compreens&#227;o. Pacientes com n&#237;veis press&#243;ricos acima de 180/110 mmHg ou com sintomas como dor precordial ou cefaleia intensa ter&#227;o consultas presenciais agendadas.</p>
      </sec>
      <sec>
        <title>Visita final (V2)</title>
        <p>A V2 ser&#225; feita para ambos os grupos ao final do treinamento proposto, com janela aceit&#225;vel de &#177; tr&#234;s dias. Todos ser&#227;o submetidos aos mesmos procedimentos de V0.</p>
      </sec>
      <sec>
        <title>Grupo interven&#231;&#227;o</title>
        <p>A interven&#231;&#227;o ter&#225; in&#237;cio na manh&#227; seguinte &#224; finaliza&#231;&#227;o de V0, com dura&#231;&#227;o de 12 semanas. Esse tempo de seguimento foi utilizado em estudos com interven&#231;&#245;es n&#227;o medicamentosas em hipertensos, e demonstrou ser suficiente para obter mudan&#231;as nos valores press&#243;ricos. <sup><xref ref-type="bibr" rid="B33">33</xref> , <xref ref-type="bibr" rid="B34">34</xref></sup> A interven&#231;&#227;o consistir&#225; em uma sequ&#234;ncia de v&#237;deos previamente gravados, mensagens, tarefas curtas relacionadas ao tema do v&#237;deo e dias de folga ( <xref ref-type="table" rid="t1">Tabela 1</xref> ). Ser&#227;o abordados assuntos ligados &#224; espiritualidade, como perd&#227;o, gratid&#227;o, otimismo, prop&#243;sito de vida e bem-estar espiritual. O conte&#250;do ser&#225; disponibilizado diariamente em um aplicativo para smartphone, que registrar&#225; as atividades realizadas por cada participante.</p>
        <p>
          <table-wrap id="t1">
            <label>Tabela 1</label>
            <caption>
              <title>Sequ&#234;ncia de tarefas por dia da semana do grupo interven&#231;&#227;o</title>
            </caption>
            <table frame="hsides" rules="groups">
              <colgroup width="13%">
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
                <col/>
              </colgroup>
              <thead>
                <tr>
                  <th>Dia</th>
                  <th>Tarefa</th>
                  <th>Dia</th>
                  <th>Tarefa</th>
                  <th>Dia</th>
                  <th>Tarefa</th>
                  <th>Dia</th>
                  <th>Tarefa</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td align="center">1</td>
                  <td align="center">V 1</td>
                  <td align="center">22</td>
                  <td align="center">AT 6</td>
                  <td align="center">43</td>
                  <td align="center">F</td>
                  <td align="center">64</td>
                  <td align="center">MR 22</td>
                </tr>
                <tr>
                  <td align="center">2</td>
                  <td align="center">MR 1</td>
                  <td align="center">23</td>
                  <td align="center">MR 8</td>
                  <td align="center">44</td>
                  <td align="center">V 9</td>
                  <td align="center">65</td>
                  <td align="center">AT 21</td>
                </tr>
                <tr>
                  <td align="center">3</td>
                  <td align="center">AT 1</td>
                  <td align="center">24</td>
                  <td align="center">F</td>
                  <td align="center">45</td>
                  <td align="center">MR 15</td>
                  <td align="center">66</td>
                  <td align="center">F</td>
                </tr>
                <tr>
                  <td align="center">4</td>
                  <td align="center">F</td>
                  <td align="center">25</td>
                  <td align="center">V 6</td>
                  <td align="center">46</td>
                  <td align="center">AT 14</td>
                  <td align="center">67</td>
                  <td align="center">V 12</td>
                </tr>
                <tr>
                  <td align="center">5</td>
                  <td align="center">V 2</td>
                  <td align="center">26</td>
                  <td align="center">MR 9</td>
                  <td align="center">47</td>
                  <td align="center">MR 16</td>
                  <td align="center">68</td>
                  <td align="center">MR 23</td>
                </tr>
                <tr>
                  <td align="center">6</td>
                  <td align="center">MR 2</td>
                  <td align="center">27</td>
                  <td align="center">AT 7</td>
                  <td align="center">48</td>
                  <td align="center">AT 15</td>
                  <td align="center">69</td>
                  <td align="center">AT 22</td>
                </tr>
                <tr>
                  <td align="center">7</td>
                  <td align="center">AT 2</td>
                  <td align="center">28</td>
                  <td align="center">MR 10</td>
                  <td align="center">49</td>
                  <td align="center">MR 17</td>
                  <td align="center">70</td>
                  <td align="center">MR 24</td>
                </tr>
                <tr>
                  <td align="center">8</td>
                  <td align="center">F</td>
                  <td align="center">29</td>
                  <td align="center">AT 8</td>
                  <td align="center">50</td>
                  <td align="center">AT 16</td>
                  <td align="center">71</td>
                  <td align="center">AT 23</td>
                </tr>
                <tr>
                  <td align="center">9</td>
                  <td align="center">V 3</td>
                  <td align="center">30</td>
                  <td align="center">F</td>
                  <td align="center">51</td>
                  <td align="center">F</td>
                  <td align="center">72</td>
                  <td align="center">F</td>
                </tr>
                <tr>
                  <td align="center">10</td>
                  <td align="center">MR 3</td>
                  <td align="center">31</td>
                  <td align="center">V 7</td>
                  <td align="center">52</td>
                  <td align="center">V 10</td>
                  <td align="center">73</td>
                  <td align="center">V 13</td>
                </tr>
                <tr>
                  <td align="center">11</td>
                  <td align="center">AT 3</td>
                  <td align="center">32</td>
                  <td align="center">MR 11</td>
                  <td align="center">53</td>
                  <td align="center">MR 18</td>
                  <td align="center">74</td>
                  <td align="center">MR 25</td>
                </tr>
                <tr>
                  <td align="center">12</td>
                  <td align="center">F</td>
                  <td align="center">33</td>
                  <td align="center">AT 9</td>
                  <td align="center">54</td>
                  <td align="center">AT 17</td>
                  <td align="center">75</td>
                  <td align="center">AT 24</td>
                </tr>
                <tr>
                  <td align="center">13</td>
                  <td align="center">V 4</td>
                  <td align="center">34</td>
                  <td align="center">AT 10</td>
                  <td align="center">55</td>
                  <td align="center">MR 19</td>
                  <td align="center">76</td>
                  <td align="center">MR 26</td>
                </tr>
                <tr>
                  <td align="center">14</td>
                  <td align="center">MR 4</td>
                  <td align="center">35</td>
                  <td align="center">MR 12</td>
                  <td align="center">56</td>
                  <td align="center">F</td>
                  <td align="center">77</td>
                  <td align="center">F</td>
                </tr>
                <tr>
                  <td align="center">15</td>
                  <td align="center">AT 4</td>
                  <td align="center">36</td>
                  <td align="center">AT 11</td>
                  <td align="center">57</td>
                  <td align="center">V 11</td>
                  <td align="center">78</td>
                  <td align="center">V 14</td>
                </tr>
                <tr>
                  <td align="center">16</td>
                  <td align="center">MR 5</td>
                  <td align="center">37</td>
                  <td align="center">AT 12</td>
                  <td align="center">58</td>
                  <td align="center">MR 20</td>
                  <td align="center">79</td>
                  <td align="center">MR 27</td>
                </tr>
                <tr>
                  <td align="center">17</td>
                  <td align="center">F</td>
                  <td align="center">38</td>
                  <td align="center">F</td>
                  <td align="center">59</td>
                  <td align="center">AT 18</td>
                  <td align="center">80</td>
                  <td align="center">MR 28</td>
                </tr>
                <tr>
                  <td align="center">18</td>
                  <td align="center">V 5</td>
                  <td align="center">39</td>
                  <td align="center">V 8</td>
                  <td align="center">60</td>
                  <td align="center">MR 21</td>
                  <td align="center">81</td>
                  <td align="center">F</td>
                </tr>
                <tr>
                  <td align="center">19</td>
                  <td align="center">MR 6</td>
                  <td align="center">40</td>
                  <td align="center">MR 13</td>
                  <td align="center">61</td>
                  <td align="center">AT 19</td>
                  <td align="center">82</td>
                  <td align="center">V 15</td>
                </tr>
                <tr>
                  <td align="center">20</td>
                  <td align="center">AT 5</td>
                  <td align="center">41</td>
                  <td align="center">AT 13</td>
                  <td align="center">62</td>
                  <td align="center">F</td>
                  <td align="center">83</td>
                  <td align="center">MR 29</td>
                </tr>
                <tr>
                  <td align="center">21</td>
                  <td align="center">MR 7</td>
                  <td align="center">42</td>
                  <td align="center">MR 14</td>
                  <td align="center">63</td>
                  <td align="center">AT 20</td>
                  <td align="center">84</td>
                  <td align="center">AT 25</td>
                </tr>
              </tbody>
            </table>
            <table-wrap-foot>
              <fn id="TFN1">
                <p>
                  <italic>V: v&#237;deo; MR: mensagem de reflex&#227;o; AT: atividade; F: folga.</italic>
                </p>
              </fn>
            </table-wrap-foot>
          </table-wrap>
        </p>
        <p>Ser&#227;o considerados participantes com ades&#227;o satisfat&#243;ria &#224; interven&#231;&#227;o aqueles que realizarem pelo menos 75% das tarefas propostas.</p>
      </sec>
      <sec>
        <title>Grupo controle</title>
        <p>O GC ser&#225; acompanhado nos servi&#231;os dentro da mesma periodicidade definida para o GI. Se observamos resultados superiores no GI, o GC receber&#225; o mesmo tratamento ap&#243;s a conclus&#227;o do estudo.</p>
      </sec>
      <sec>
        <title>An&#225;lise dos dados</title>
        <p>Os dados coletados ser&#227;o analisados com a utiliza&#231;&#227;o do Software Stata 14.0. As vari&#225;veis qualitativas ser&#227;o apresentadas com m&#233;dia e desvio padr&#227;o e as quantitativas com m&#233;dia e desvio padr&#227;o ou mediana e intervalo interquartil.</p>
        <p>A distribui&#231;&#227;o dos dados das vari&#225;veis ser&#225; verificada quanto &#224; normalidade com o teste de Kolmogorov Smirnov. Ser&#227;o aplicados testes de acordo com a normalidade dos dados para a avalia&#231;&#227;o entre os grupos (interven&#231;&#227;o e controle) e intra-grupo (antes e depois) para cada um deles. Se o caso, ser&#225; realizada a an&#225;lise &#8220;intention-to-treat&#8221;, e somente com pacientes que completaram o protocolo do estudo.</p>
        <p>O desfecho prim&#225;rio do estudo ser&#225; a press&#227;o arterial sist&#243;lica perif&#233;rica e os desfechos secund&#225;rios ser&#227;o: a PASc, a VOP, a PAS m&#233;dia e a DFM.</p>
      </sec>
      <sec>
        <title>Aspectos &#233;ticos</title>
        <p>O projeto foi submetido e aprovado pelo Comit&#234; de &#201;tica em Pesquisa do Hospital das Cl&#237;nicas da UFG.</p>
      </sec>
    </sec>
    <sec sec-type="conclusions">
      <title>Conclus&#227;o</title>
      <p>Esta pesquisa buscar&#225; compreender o efeito de uma interven&#231;&#227;o do est&#237;mulo e treinamento para a busca do bem-estar espiritual por meio da propens&#227;o ao perd&#227;o, otimismo, gratid&#227;o e prop&#243;sito de vida no comportamento da press&#227;o arterial.</p>
      <p>O estudo poder&#225; impactar positivamente a pr&#225;tica cl&#237;nica ao trazer embasamento para uma abordagem n&#227;o farmacol&#243;gica para o tratamento da HA al&#233;m de ser, em nosso conhecimento, um dos primeiros ensaios cl&#237;nicos com esse desenho.</p>
    </sec>
  </body>
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    <fn-group>
      <fn fn-type="other">
        <label/>
        <p>Vincula&#231;&#227;o acad&#234;mica</p>
        <p>Este artigo &#233; parte de tese de doutorado de Maria Em&#237;lia Figueiredo Teixeira pela Liga de hipertens&#227;o arterial da Universidade Federal de Goi&#225;s.</p>
      </fn>
    </fn-group>
    <fn-group>
      <fn fn-type="supported-by">
        <p>Fontes de financiamento: O presente estudo n&#227;o teve fontes de financiamento externas.</p>
      </fn>
    </fn-group>
  </back>
  <sub-article article-type="translation" id="TRen" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Research Letter</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Influence of Spiritual Well-Being on Blood Pressure, Central Hemodynamics and Endothelial Function</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-4785-9651</contrib-id>
          <name>
            <surname>Teixeira</surname>
            <given-names>Maria Em&#237;lia Figueiredo</given-names>
          </name>
          <xref ref-type="aff" rid="aff1001">
            <sup>1</sup>
          </xref>
          <xref ref-type="aff" rid="aff2001">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-5487-4649</contrib-id>
          <name>
            <surname>Vitorino</surname>
            <given-names>Priscila Valverde de Oliveira</given-names>
          </name>
          <xref ref-type="aff" rid="aff3001">
            <sup>3</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-7040-396X</contrib-id>
          <name>
            <surname>Brand&#227;o</surname>
            <given-names>Andrea A.</given-names>
          </name>
          <xref ref-type="aff" rid="aff4001">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Souza</surname>
            <given-names>Ana Luiza Lima</given-names>
          </name>
          <xref ref-type="aff" rid="aff1001">
            <sup>1</sup>
          </xref>
          <xref ref-type="aff" rid="aff2001">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Barbosa</surname>
            <given-names>Talles Marcelo Gon&#231;alves de Andrade</given-names>
          </name>
          <xref ref-type="aff" rid="aff5001">
            <sup>5</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Esporcatte</surname>
            <given-names>Roberto</given-names>
          </name>
          <xref ref-type="aff" rid="aff4001">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Borba</surname>
            <given-names>M&#225;rio Henrique Elesb&#227;o de</given-names>
          </name>
          <xref ref-type="aff" rid="aff6001">
            <sup>6</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Avezum</surname>
            <given-names>&#193;lvaro</given-names>
          </name>
          <xref ref-type="aff" rid="aff7001">
            <sup>7</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0002-1265-1930</contrib-id>
          <name>
            <surname>Barroso</surname>
            <given-names>Weimar Kunz Sebba</given-names>
          </name>
          <xref ref-type="aff" rid="aff1001">
            <sup>1</sup>
          </xref>
        </contrib>
      </contrib-group>
      <aff id="aff1001">
        <label>1</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Universidade Federal de Goi&#225;s &#8211; Liga de Hipertens&#227;o Arterial, Goi&#226;nia, GO &#8211; Brazil</institution>
      </aff>
      <aff id="aff2001">
        <label>2</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Universidade Federal de Goi&#225;s &#8211; Programa de P&#243;s-Gradua&#231;&#227;o em Ci&#234;ncias da Sa&#250;de, Goi&#226;nia, GO &#8211; Brazil</institution>
      </aff>
      <aff id="aff3001">
        <label>3</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s &#8211; Escola de Ci&#234;ncias Sociais e da Sa&#250;de, Goi&#226;nia, GO &#8211; Brazil</institution>
      </aff>
      <aff id="aff4001">
        <label>4</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Universidade do Estado do Rio de Janeiro &#8211; Departamento de Doen&#231;as do T&#243;rax, Rio de Janeiro, RJ &#8211; Brazil</institution>
      </aff>
      <aff id="aff5001">
        <label>5</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Pontif&#237;cia Universidade Cat&#243;lica de Goi&#225;s &#8211; Escola de Ci&#234;ncias Exatas e da Computa&#231;&#227;o (ECEC), Goi&#226;nia, GO &#8211; Brazil</institution>
      </aff>
      <aff id="aff6001">
        <label>6</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Cardio Cl&#237;nica do Vale, Lajeado, RS &#8211; Brazil</institution>
      </aff>
      <aff id="aff7001">
        <label>7</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">International Research Center, Hospital Alem&#227;o Oswaldo Cruz, S&#227;o Paulo, SP &#8211; Brazil</institution>
      </aff>
      <author-notes>
        <corresp id="c01001">Mailing Address: Maria Em&#237;lia Figueiredo Teixeira &#8226; Universidade Federal de Goi&#225;s &#8211; Liga de Hipertens&#227;o Arterial e Programa de P&#243;s-Gradua&#231;&#227;o em Ci&#234;ncias da Sa&#250;de &#8211; R. 235, s/n. Postal code 74605-050, Setor Leste Universit&#225;rio, Goi&#226;nia, GO &#8211; Brazil E-mail: emiliateixeiracardio@gmail.com</corresp>
        <fn fn-type="con">
          <p>Author Contributions</p>
          <p>Conception and design of the research: Teixeira MEF, Vitorino PVO, Brand&#227;o AA, Souza ALL, Barbosa TMGA, Esporcatte R, Borba MHE, Avezum A, Barroso WKS; Statistical analysis: Vitorino PVO; Writing of the manuscript: Teixeira MEF; Critical revision of the manuscript for important intellectual content: Vitorino PVO, Brand&#227;o AA, Souza ALL, Avezum A, Barroso WKS.</p>
        </fn>
        <fn fn-type="conflict">
          <p>Potential Conflict of Interest</p>
          <p>No potential conflict of interest relevant to this article was reported.</p>
        </fn>
      </author-notes>
      <kwd-group xml:lang="en">
        <kwd>Spirituality</kwd>
        <kwd>Religion and Medicine</kwd>
        <kwd>Blood Pressure</kwd>
        <kwd>Hemodynamic</kwd>
        <kwd>Endothelium/physiology</kwd>
        <kwd>Social Values</kwd>
        <kwd>Value of Life</kwd>
        <kwd>Quality of Life</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <disp-quote>
        <p>&#8220; <italic>Science is not only compatible with spirituality; it is a profound source of spirituality.</italic> &#8221;</p>
        <p>
          <bold>Carl Sagan</bold>
        </p>
      </disp-quote>
      <sec sec-type="intro">
        <title>Introduction</title>
        <p>Spirituality<sup><xref ref-type="bibr" rid="B1">1</xref></sup> and religiosity (S/R) are cultural aspects that have existed since the beginnings of human existence. Having been long considered as opponent to science, only recently, S/R have gained importance in the context of health.<sup><xref ref-type="bibr" rid="B1">1</xref></sup></p>
        <p>Definitions of S/R have been constantly evolving, according to the need for adaptation to new knowledge. Today, religion has been related to organizational, institutional and dogmatic aspects, that is, the contact with deity occurs through predetermined formats, specific to each religious segment.<sup><xref ref-type="bibr" rid="B2">2</xref></sup> Spirituality is a wider term, encompassing a quest for personal, psychological and spiritual well-being, and good-quality interpersonal relationships. According to the Department of Studies in Spirituality and Cardiovascular Medicine (DEMCA, <italic>Departamento de Estudos em Espiritualidade e Medicina Cardiovascular</italic> ) of the Brazilian Cardiology Society, &#8220;spirituality is a set of moral, mental and emotional values that guide thoughts, behaviors and attitudes in life circumstances of intra and interpersonal relationships&#8221;.<sup><xref ref-type="bibr" rid="B3">3</xref></sup></p>
        <p>Arterial hypertension (AH) is a highly prevalent disease and the main risk factor for cardiovascular diseases,<sup><xref ref-type="bibr" rid="B4">4</xref></sup> and hence the main direct and indirect cause of mortality in the world.<sup><xref ref-type="bibr" rid="B5">5</xref></sup> Since AH is a multifactorial disease, its treatment encompasses both pharmacological and non-pharmacological strategies,<sup><xref ref-type="bibr" rid="B6">6</xref></sup> focusing on physical and mental well-being.<sup><xref ref-type="bibr" rid="B7">7</xref> , <xref ref-type="bibr" rid="B8">8</xref></sup></p>
        <p>Practices that promote spiritual well-being, allied or not to religiosity, have been associated with the good control of many diseases<sup><xref ref-type="bibr" rid="B9">9</xref></sup> and reduction of mortality in several situations.<sup><xref ref-type="bibr" rid="B10">10</xref></sup> There has been evidence of an association between E/R and positive outcomes in heart diseases, such as coronary artery disease (CAD),<sup><xref ref-type="bibr" rid="B11">11</xref></sup> heart failure (HF),<sup><xref ref-type="bibr" rid="B12">12</xref></sup> and AH.<sup><xref ref-type="bibr" rid="B13">13</xref> , <xref ref-type="bibr" rid="B14">14</xref></sup></p>
        <p>S/R studies are still incipient, and mostly observational. In general, E/R have been associated with better life habits (less sedentarism, alcohol consumption and smoking),<sup><xref ref-type="bibr" rid="B15">15</xref></sup> lower blood pressure (BP), lower risk for AH,<sup><xref ref-type="bibr" rid="B16">16</xref></sup> and better treatment compliance.<sup><xref ref-type="bibr" rid="B17">17</xref></sup> Spiritual well-being alone may be a cardioprotective factor, as it is correlated with lower levels of BP, fasting glucose, triglycerides and low-density lipoprotein (LDL) cholesterol.<sup><xref ref-type="bibr" rid="B18">18</xref></sup> On the other hand, an observational study reported an increased likelihood of AH associated with higher frequency of prayer, but a lower likelihood of hypertension associated with variables for meaning and forgiveness.<sup><xref ref-type="bibr" rid="B19">19</xref></sup></p>
        <p>In light of this, it is important to evaluate the effect of an intervention focusing on spiritual well-being on the control of BP and other hemodynamic parameters. This paper describes the methodology of a clinical trial to evaluate the effects of an intervention in spirituality on peripheral and central BP (cBP) (parameters of arterial stiffness and endothelial function) in hypertensive patients in stages 1 and 2, at low or moderate cardiovascular risk. The parameters of a control group (CG) and an intervention group (IG) will be analyzed before and after 12 months of follow-up in each group and between the groups.</p>
      </sec>
      <sec sec-type="methods">
        <title>Methods</title>
        <sec>
          <title>Type and place of study</title>
          <p>This is a randomized non-inferiority trial; data collection will be carried out in the University of Goias Hypertension League ( <italic>Liga de Hipertens&#227;o Arterial da Universidade Federal de Goi&#225;s</italic> ) and in the Rio de Janeiro State University ( <italic>Universidade do Estado do Rio de Janeiro</italic> ). The protocol will be registered on the Brazilian Registry of Clinical Trials (ReCEB, <italic>Registro Brasileiro de Ensaios Cl&#237;nicos</italic> ).</p>
        </sec>
        <sec>
          <title>Population, sample, and sampling</title>
          <p>The study population will be composed of hypertensive adults (stage 1 or 2) at low or moderate cardiovascular risk, under stable treatment with antihypertensive medications for more than 30 days, which was evaluated by BP measures taken during the last visit.</p>
          <p>Sample calculation was performed using the OpenEpi calculator. A systolic blood pressure (SBP) of 130.9 &#177; 9.2 and 135.81 &#177; 9.3 mmHg<sup><xref ref-type="bibr" rid="B20">20</xref></sup> was considered in the IG and the CG, respectively, with a 95% confidence interval and an 80% power of test, with 54 participants in each group.</p>
          <p>Stage 3 hypertensive patients (SBP &#8805; 180 mmHg and/or diastolic blood pressure [DBP] &#8805; 110mmHg) will be excluded.</p>
          <p>After patient enrollment, patients who decline to participate in any procedure, and/or show a rise in BP during the follow-up, preventing their participation in the study without changing the drug regimen will be excluded.</p>
        </sec>
        <sec>
          <title>Patient recruitment and randomization</title>
          <p>The staffs involved in the study will meet for the presentation and discussion about the project, and training of the members for the correct execution of the protocol and uniformization of patient approach, for the sake of methodological rigor.</p>
          <p>Patients will be selected based on the last BP recorded in the medical record, and on the classification of AH stage and cardiovascular risk, and will be invited to participate in the study by telephone. Those who accept to participate will be invited for the first visit.</p>
        </sec>
        <sec>
          <title>First visit (V0)</title>
          <p>Randomization of participants into one of the two groups will be performed by using www. randomizer.org.</p>
          <p>All patients will receive information about healthy life habits. Then, the medical history will be taken, and clinical examination and interview will be performed for completion of four questionnaires &#8211; Durel,<sup><xref ref-type="bibr" rid="B21">21</xref> , <xref ref-type="bibr" rid="B22">22</xref></sup> willingness to forgive,<sup><xref ref-type="bibr" rid="B23">23</xref></sup> the gratitude questionnaire,<sup><xref ref-type="bibr" rid="B24">24</xref></sup> and the spiritual well-being questionnaire.<sup><xref ref-type="bibr" rid="B25">25</xref></sup> All procedures will be performed by trained investigators, following the same script, to standardize the visits and instructions.</p>
          <p>In addition, casual BP will be measured by oscillometry using a Dyna-MAPA AOP device (Cardios, Brazil), that provides measurements of peripheral BP, central BP (cBP), pulse wave velocity (PWV) (using an algorithm and ARC SOLVER equation and expressed as meter/second), and the augmentation index adjusted to 75% of the heart rate (AIx).<sup><xref ref-type="bibr" rid="B26">26</xref> , <xref ref-type="bibr" rid="B27">27</xref></sup> Peripheral BP measurements will be obtained according to the latest Brazilian guidelines on hypertension.<sup><xref ref-type="bibr" rid="B8">8</xref></sup></p>
          <p>Ambulatory blood pressure monitoring (ABPM) will be performed using a Dyna-MAPA AOP device (Cardios, Brazil), following the latest Brazilian guidelines on ABPM.<sup><xref ref-type="bibr" rid="B28">28</xref></sup></p>
          <p>Flow-mediated dilation (FMD) will be determined by a high-resolution ultrasound scanner and a robotic arm to obtain a precise positioning and measurement of the brachial artery (UNEX EF 38G), according to the technique proposed by Celermajer et al.<sup><xref ref-type="bibr" rid="B29">29</xref></sup> and recommendations of the International Brachial Artery Reactivity Task Force.<sup><xref ref-type="bibr" rid="B30">30</xref> , <xref ref-type="bibr" rid="B31">31</xref></sup> FMD is the current gold standard method to evaluate endothelial function; a FMD &gt; 10% indicates a healthy endothelium, and values below that are predictive of increased cardiovascular risk.<sup><xref ref-type="bibr" rid="B32">32</xref></sup></p>
        </sec>
        <sec>
          <title>Intermediate visit (V1)</title>
          <p>An intermediate visit will be held six weeks after V0, by telephone call, to verify patient well-being and encourage adherence to the intervention (IG), highlighting the importance of performing the daily activities proposed and clarifying possible doubts. In-person visits will be scheduled with patients with BP levels above 180/110mmHg and patients with symptoms such as precordial pain or severe headache.</p>
        </sec>
        <sec>
          <title>Final visit (V2)</title>
          <p>The final visit will be held for both IG and CG after the program proposed, with an acceptable time window of &#177; three days. All patients will undergo the same procedures of V0.</p>
        </sec>
        <sec>
          <title>Intervention group</title>
          <p>The intervention will begin in the morning after the V0 and have a duration of 12 weeks. This follow-up period was used in previous non-pharmacological intervention studies with hypertensive patients and shown to be sufficient to detect changes in BP.<sup><xref ref-type="bibr" rid="B33">33</xref> , <xref ref-type="bibr" rid="B34">34</xref></sup></p>
          <p>The intervention will consist of a series of previously recorded videos, messages, short tasks related to the subject of the video and days off ( <xref ref-type="table" rid="t1001">Table 1</xref> ). Themes related to spirituality, forgiveness, gratitude, optimism, life purpose, and spiritual well-being will be addressed. The content will be available through a smartphone app, which will register the activities performed by each participant daily.</p>
          <p>
            <table-wrap id="t1001">
              <label>Table 1</label>
              <caption>
                <title>Sequence of tasks by weekday for the intervention group</title>
              </caption>
              <table frame="hsides" rules="groups">
                <colgroup>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                  <col/>
                </colgroup>
                <thead>
                  <tr>
                    <th>Day</th>
                    <th>Task</th>
                    <th>Day</th>
                    <th>Task</th>
                    <th>Day</th>
                    <th>Task</th>
                    <th>Day</th>
                    <th>Task</th>
                  </tr>
                </thead>
                <tbody>
                  <tr>
                    <td align="center">1</td>
                    <td align="center">V 1</td>
                    <td align="center">22</td>
                    <td align="center">AT 6</td>
                    <td align="center">43</td>
                    <td align="center">R</td>
                    <td align="center">64</td>
                    <td align="center">TM 22</td>
                  </tr>
                  <tr>
                    <td align="center">2</td>
                    <td align="center">TM 1</td>
                    <td align="center">23</td>
                    <td align="center">TM 8</td>
                    <td align="center">44</td>
                    <td align="center">V 9</td>
                    <td align="center">65</td>
                    <td align="center">AT 21</td>
                  </tr>
                  <tr>
                    <td align="center">3</td>
                    <td align="center">AT 1</td>
                    <td align="center">24</td>
                    <td align="center">R</td>
                    <td align="center">45</td>
                    <td align="center">TM 15</td>
                    <td align="center">66</td>
                    <td align="center">R</td>
                  </tr>
                  <tr>
                    <td align="center">4</td>
                    <td align="center">R</td>
                    <td align="center">25</td>
                    <td align="center">V 6</td>
                    <td align="center">46</td>
                    <td align="center">AT 14</td>
                    <td align="center">67</td>
                    <td align="center">V 12</td>
                  </tr>
                  <tr>
                    <td align="center">5</td>
                    <td align="center">V 2</td>
                    <td align="center">26</td>
                    <td align="center">TM 9</td>
                    <td align="center">47</td>
                    <td align="center">TM 16</td>
                    <td align="center">68</td>
                    <td align="center">TM 23</td>
                  </tr>
                  <tr>
                    <td align="center">6</td>
                    <td align="center">TM 2</td>
                    <td align="center">27</td>
                    <td align="center">AT 7</td>
                    <td align="center">48</td>
                    <td align="center">AT 15</td>
                    <td align="center">69</td>
                    <td align="center">AT 22</td>
                  </tr>
                  <tr>
                    <td align="center">7</td>
                    <td align="center">AT 2</td>
                    <td align="center">28</td>
                    <td align="center">TM 10</td>
                    <td align="center">49</td>
                    <td align="center">TM 17</td>
                    <td align="center">70</td>
                    <td align="center">TM 24</td>
                  </tr>
                  <tr>
                    <td align="center">8</td>
                    <td align="center">R</td>
                    <td align="center">29</td>
                    <td align="center">AT 8</td>
                    <td align="center">50</td>
                    <td align="center">AT 16</td>
                    <td align="center">71</td>
                    <td align="center">AT 23</td>
                  </tr>
                  <tr>
                    <td align="center">9</td>
                    <td align="center">V 3</td>
                    <td align="center">30</td>
                    <td align="center">R</td>
                    <td align="center">51</td>
                    <td align="center">R</td>
                    <td align="center">72</td>
                    <td align="center">R</td>
                  </tr>
                  <tr>
                    <td align="center">10</td>
                    <td align="center">TM 3</td>
                    <td align="center">31</td>
                    <td align="center">V 7</td>
                    <td align="center">52</td>
                    <td align="center">V 10</td>
                    <td align="center">73</td>
                    <td align="center">V 13</td>
                  </tr>
                  <tr>
                    <td align="center">11</td>
                    <td align="center">AT 3</td>
                    <td align="center">32</td>
                    <td align="center">TM 11</td>
                    <td align="center">53</td>
                    <td align="center">TM 18</td>
                    <td align="center">74</td>
                    <td align="center">TM 25</td>
                  </tr>
                  <tr>
                    <td align="center">12</td>
                    <td align="center">R</td>
                    <td align="center">33</td>
                    <td align="center">AT 9</td>
                    <td align="center">54</td>
                    <td align="center">AT 17</td>
                    <td align="center">75</td>
                    <td align="center">AT 24</td>
                  </tr>
                  <tr>
                    <td align="center">13</td>
                    <td align="center">V 4</td>
                    <td align="center">34</td>
                    <td align="center">AT 10</td>
                    <td align="center">55</td>
                    <td align="center">TM 19</td>
                    <td align="center">76</td>
                    <td align="center">TM 26</td>
                  </tr>
                  <tr>
                    <td align="center">14</td>
                    <td align="center">TM 4</td>
                    <td align="center">35</td>
                    <td align="center">TM 12</td>
                    <td align="center">56</td>
                    <td align="center">R</td>
                    <td align="center">77</td>
                    <td align="center">R</td>
                  </tr>
                  <tr>
                    <td align="center">15</td>
                    <td align="center">AT 4</td>
                    <td align="center">36</td>
                    <td align="center">AT 11</td>
                    <td align="center">57</td>
                    <td align="center">V 11</td>
                    <td align="center">78</td>
                    <td align="center">V 14</td>
                  </tr>
                  <tr>
                    <td align="center">16</td>
                    <td align="center">TM 5</td>
                    <td align="center">37</td>
                    <td align="center">AT 12</td>
                    <td align="center">58</td>
                    <td align="center">TM 20</td>
                    <td align="center">79</td>
                    <td align="center">TM 27</td>
                  </tr>
                  <tr>
                    <td align="center">17</td>
                    <td align="center">R</td>
                    <td align="center">38</td>
                    <td align="center">R</td>
                    <td align="center">59</td>
                    <td align="center">AT 18</td>
                    <td align="center">80</td>
                    <td align="center">TM 28</td>
                  </tr>
                  <tr>
                    <td align="center">18</td>
                    <td align="center">V 5</td>
                    <td align="center">39</td>
                    <td align="center">V 8</td>
                    <td align="center">60</td>
                    <td align="center">TM 21</td>
                    <td align="center">81</td>
                    <td align="center">R</td>
                  </tr>
                  <tr>
                    <td align="center">19</td>
                    <td align="center">TM 6</td>
                    <td align="center">40</td>
                    <td align="center">TM 13</td>
                    <td align="center">61</td>
                    <td align="center">AT 19</td>
                    <td align="center">82</td>
                    <td align="center">V 15</td>
                  </tr>
                  <tr>
                    <td align="center">20</td>
                    <td align="center">AT 5</td>
                    <td align="center">41</td>
                    <td align="center">AT 13</td>
                    <td align="center">62</td>
                    <td align="center">R</td>
                    <td align="center">83</td>
                    <td align="center">TM 29</td>
                  </tr>
                  <tr>
                    <td align="center">21</td>
                    <td align="center">TM 7</td>
                    <td align="center">42</td>
                    <td align="center">TM 14</td>
                    <td align="center">63</td>
                    <td align="center">AT 20</td>
                    <td align="center">84</td>
                    <td align="center">AT 25</td>
                  </tr>
                </tbody>
              </table>
              <table-wrap-foot>
                <fn id="TFN1001">
                  <p>
                    <italic>V: video; TM: thinking message; AT: activity; R: respite</italic>
                  </p>
                </fn>
              </table-wrap-foot>
            </table-wrap>
          </p>
          <p>The adherence to the intervention will be considered satisfactory when 75% or more of the proposed tasks are completed.</p>
        </sec>
        <sec>
          <title>Control group</title>
          <p>The CG will be monitored at the same frequency as the IG. If the results in the IG are significantly better than in the CG, the latter will receive the same treatment at the end of the study period.</p>
        </sec>
        <sec>
          <title>Statistical analysis</title>
          <p>Data will be analyzed using the Software Stata 14.0. Qualitative variables will be expressed as mean and standard deviation, and quantitative variables as mean and standard deviation or median and interquartile range.</p>
          <p>Normality of data distribution will be tested by the Kolmogorov-Smirnov test. Statistical tests will be applied according to normality of the data for between-group (IG and CG) and within-group comparisons (before and after). If this is the case, the intention-to-treat analysis will be performed, and only with patients who complete the study protocol.</p>
          <p>The primary outcome will be peripheral systolic blood pressure and the secondary outcomes will be: cSBP, PWV, mean SBP and FMD.</p>
        </sec>
        <sec>
          <title>Ethical aspects</title>
          <p>The project was submitted and approved by the Ethics Committee of the UFG General Hospital.</p>
        </sec>
      </sec>
      <sec sec-type="conclusions">
        <title>Conclusion</title>
        <p>This research will investigate the effects of an intervention based on encouragement and training to achieve spiritual well-being through propensity to forgive, optimism, gratitude, and life purpose on BP behavior.</p>
        <p>The study will have a positive impact on clinical practice by presenting the basis for a non-pharmacological approach to the treatment of AH. Also, to our knowledge, this is one of the first clinical trials with this design.</p>
      </sec>
    </body>
    <back>
      <fn-group>
        <fn fn-type="other">
          <label/>
          <p>Study Association</p>
          <p>This article is part of the thesis of master submitted by Maria Em&#237;lia Figueiredo Teixeira, from Liga de hipertens&#227;o arterial da Universidade Federal de Goi&#225;s.</p>
        </fn>
      </fn-group>
      <fn-group>
        <fn fn-type="supported-by">
          <p>Sources of Funding: There were no external funding sources for this study.</p>
        </fn>
      </fn-group>
    </back>
  </sub-article>
</article>
