An interventional study of Roy Adaptation Model-Based Prenatal Education in Hypertensive Disorders of Pregnancy (HDP), sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Other
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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.
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.
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's planned enrollment of 54 is below the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →Istanbul University - Cerrahpasa is the lead sponsor of 701 studies on the registry; 211 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: At baseline (before the first education session) and 2 weeks after baseline
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.
Time frame: At baseline (before the first education session) and 2 weeks after baseline
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2027, 3 months later.
Of 90 non-industry interventional studies with no phase under Hypertension, Pregnancy-Induced, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 3 months is below that.
Counting every sponsor, half of 91 studies reached it within 23 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hypertension, Pregnancy-Induced →
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