Hypertensive Disorders of Pregnancy (HDP)NCT07820306
Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women
A study testing Roy Adaptation Model-Based Prenatal Education in people with Hypertensive Disorders of Pregnancy (HDP), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy (HDP)
- What is being tested?
- Roy Adaptation Model-Based Prenatal Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2026to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, 34384
Esra Erdem, midwife, +90 537 011 59 36 ext. yok, esra.erdem@ogr.iuc.edu.tr
Esra Erdem, Midwife
About this study
Official title: 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.
Read the 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.
- Being tested
- Roy Adaptation Model-Based Prenatal Education
- Keywords
- Gestational Hypertension, Hypertensive Disorders of Pregnancy, Prenatal Education, Roy adaptation model, Perceived Stress, Quality of Life, Pregnant Women, High-Risk Pregnancy, Midwifery Care
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roy Adaptation Model-Based Prenatal EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (before the first education session) and 2 weeks after baseline
Secondary outcomes (1)
Pregnancy-Related Quality of Life Score
Quality of life will be assessed using the Pregnancy Quality of Life Scale. Higher scores indicate better quality of life.
Measured: At baseline (before the first education session) and 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of Pregnancy (HDP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Erdem, Istanbul University - Cerrahpasa
- Investigators
- Sevda Korkut Öksüz, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820306
- Sponsor's protocol ID
- IUC-EBELİK-EE-01
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.