Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

September 10, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34384
        • Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
        • Contact:
        • Principal Investigator:
          • Esra Erdem, Midwife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Roy 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Level in High-Risk Pregnancies
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pregnancy-Related Quality of Life Score
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sevda Korkut Öksüz, Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IUC-EBELİK-EE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings