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Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

2026년 9월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

54

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Istanbul, 터키 (Türkiye), 34384
        • Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
        • 연락하다:
        • 수석 연구원:
          • Esra Erdem, Midwife

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Perceived Stress Level in High-Risk Pregnancies
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pregnancy-Related Quality of Life Score
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Sevda Korkut Öksüz, Istanbul University - Cerrahpasa

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 16일

기본 완료 (추정된)

2027년 1월 10일

연구 완료 (추정된)

2027년 1월 30일

연구 등록 날짜

최초 제출

2026년 9월 10일

QC 기준을 충족하는 최초 제출

2026년 9월 10일

처음 게시됨 (실제)

2026년 9월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 10일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IUC-EBELİK-EE-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .