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Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07820306
Enrollment
54
Registered
2026-09-15
Start date
2026-09-16
Completion date
2027-01-30
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

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.

Interventions

BEHAVIORALRoy Adaptation Model-Based Prenatal Education

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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress Level in High-Risk PregnanciesAt baseline (before the first education session) and 2 weeks after baselinePerceived stress level will be assessed using the High-Risk Pregnancy Perceived Stress Scale. Higher scores indicate higher perceived stress.

Secondary

MeasureTime frameDescription
Pregnancy-Related Quality of Life ScoreAt baseline (before the first education session) and 2 weeks after baselineQuality of life will be assessed using the Pregnancy Quality of Life Scale. Higher scores indicate better quality of life.

Countries

Turkey (Türkiye)

Contacts

CONTACTEsra Erdem, midwife
esra.erdem@ogr.iuc.edu.tr+90 537 011 59 36
STUDY_DIRECTORSevda Korkut Öksüz

Istanbul University - Cerrahpasa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026