Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

NCT07820306 | Not Yet Recruiting

• 1 other identifier: IUC-EBELİK-EE-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertensive Disorders of Pregnancy (HDP)

Keywords

Gestational Hypertension; Hypertensive Disorders of Pregnancy; Prenatal Education; Roy adaptation model; Perceived Stress; Quality of Life; Pregnant Women; High-Risk Pregnancy; Midwifery Care

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Level in High-Risk Pregnancies

  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

Secondary Outcomes (1)

• Pregnancy-Related Quality of Life Score

  At baseline (before the first education session) and 2 weeks after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Roy Adaptation Model-Based Prenatal Education

Control Group

NO INTERVENTION

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.

Interventions

Roy Adaptation Model-Based Prenatal Education BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sevda Korkut Öksüz

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Esra Erdem, midwife

CONTACT

+90 537 011 59 36; esra.erdem@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: midwife

Model Details: Participants will be randomly assigned to either the intervention group or the control group and will be followed in parallel throughout the study. The intervention group will receive Roy Adaptation Model-based prenatal education, while the control group will receive routine antenatal care.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)