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Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

10 de setembro de 2026 atualizado por: Esra Erdem, Istanbul University - Cerrahpasa

The Effect of Roy Adaptation Model-Based Prenatal Education on Perceived Stress and Quality of Life in Hypertensive Pregnant Women

This study aims to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders of pregnancy.

Pregnant women with hypertensive disorders who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive prenatal education based on the Roy Adaptation Model in two face-to-face sessions, one week apart. The control group will receive routine antenatal care. Blood pressure monitoring will be recommended for participants in both groups.

Perceived stress and quality of life will be assessed before the education and after the intervention. The study will investigate whether Roy Adaptation Model-based prenatal education helps reduce perceived stress and improve quality of life among pregnant women with hypertensive disorders.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

Hypertensive disorders of pregnancy are high-risk pregnancy conditions that may be associated with various maternal and fetal complications and require close monitoring throughout pregnancy. In pregnant women diagnosed with hypertensive disorders, concerns related to the disease, uncertainty about the course of pregnancy, and concerns about fetal health may increase perceived stress and negatively affect quality of life. Therefore, in addition to medical follow-up, providing education and counseling tailored to the individual needs of pregnant women and supporting their adaptation to pregnancy and the disease are important components of care.

The Roy Adaptation Model is a theoretical model that explains how individuals respond to environmental stimuli and aims to support adaptation through nursing and midwifery care. The model addresses four modes of adaptation: physiological-physical, self-concept, role function, and interdependence. Addressing the effects of the physical and psychosocial changes associated with hypertensive pregnancy on these adaptation modes may contribute to better adaptation to the pregnancy process.

In this study, prenatal education for pregnant women with hypertensive disorders has been developed based on the Roy Adaptation Model. The educational content will include information about hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals. The education will be delivered face-to-face by the researcher in two sessions, with a one-week interval between sessions.

Eligible pregnant women with hypertensive disorders will be randomly assigned to either an intervention group or a control group. The intervention group will receive Roy Adaptation Model-based prenatal education, while the control group will receive routine antenatal care. A blood pressure monitoring chart will be provided to participants in both groups.

Participants' perceived stress levels and quality of life will be assessed at the measurement time points specified in the study protocol. Sociodemographic and obstetric characteristics will also be collected using a researcher-developed introductory information form. Participants in the intervention group will provide feedback regarding the education through an education satisfaction evaluation form.

The primary aim of this study is to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders. The findings are expected to contribute to the development and implementation of theory-based prenatal education programs tailored to the needs of pregnant women with hypertensive disorders and to support evidence-based midwifery care.

Tipo de estudo

Intervencional

Inscrição (Estimado)

54

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

      • Istanbul, Turquia (Türkiye), 34384
        • Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
        • Contato:
        • Investigador principal:
          • Esra Erdem, Midwife

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Pregnant women who apply to the antenatal outpatient clinic of the relevant hospital.
  • Women diagnosed by a physician with a hypertensive disorder of pregnancy. Women who are between 20 and 32 weeks of gestation.
  • Women aged 18 years or older.
  • Primiparous or multiparous pregnant women.
  • Women who can read and understand Turkish and communicate in Turkish.
  • Women who are willing to participate in the study.

Exclusion Criteria:

  • Pregnant women with severe preeclampsia, eclampsia, HELLP syndrome, or a clinical condition requiring emergency obstetric intervention.
  • Pregnant women who are hospitalized or scheduled for hospitalization at the beginning of the study.
  • Pregnant women diagnosed with fetal anomaly or intrauterine fetal death.
  • Pregnant women with severe psychiatric, neurological, or cognitive impairment that may prevent participation in the education sessions or completion of the data collection instruments.
  • Pregnant women who develop a serious obstetric or clinical complication during the study that may affect the primary outcomes of the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention Group
Participants assigned to the intervention group will first be informed about the study and provide written informed consent. They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life. Subsequently, they will receive Roy Adaptation Model-based prenatal education in two face-to-face sessions, one week apart. Each session will last approximately 45 minutes. The education will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals. Participants will also be provided with a blood pressure monitoring chart. Following the education, post-intervention assessments of perceived stress and quality of life will be conducted. Finally, participants will complete the Education Satisfaction Evaluation Form.
Roy Adaptation Model-based prenatal education will be provided face-to-face by the researcher to pregnant women with hypertensive disorders of pregnancy. The education will be delivered in two sessions, one week apart, with each session lasting approximately 45 minutes. The educational content will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals. Participants will also receive a blood pressure monitoring chart for home monitoring. The intervention is specifically structured according to the four adaptive modes of the Roy Adaptation Model: physiological-physical, self-concept, role function, and interdependence.
Sem intervenção: Control Group
Participants assigned to the control group will first be informed about the study and provide written informed consent. They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life. Participants will continue to receive routine antenatal care throughout the study. They will also be provided with a blood pressure monitoring chart and instructed on blood pressure monitoring. No Roy Adaptation Model-based prenatal education will be provided to the control group during the study. At the end of the study follow-up period, the post-intervention assessments of perceived stress and quality of life will be conducted.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Perceived Stress Level in High-Risk Pregnancies
Prazo: At baseline (before the first education session) and 2 weeks after baseline
Perceived stress level will be assessed using the High-Risk Pregnancy Perceived Stress Scale. Higher scores indicate higher perceived stress.
At baseline (before the first education session) and 2 weeks after baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pregnancy-Related Quality of Life Score
Prazo: At baseline (before the first education session) and 2 weeks after baseline
Quality of life will be assessed using the Pregnancy Quality of Life Scale. Higher scores indicate better quality of life.
At baseline (before the first education session) and 2 weeks after baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Sevda Korkut Öksüz, Istanbul University - Cerrahpasa

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de setembro de 2026

Conclusão Primária (Estimado)

10 de janeiro de 2027

Conclusão do estudo (Estimado)

30 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de setembro de 2026

Primeira postagem (Real)

15 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant-level data will not be shared with other researchers because of participant privacy and confidentiality considerations. The data will be used solely for the purposes of this study and will be stored and handled in accordance with applicable ethical and institutional requirements.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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