Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia

June 7, 2026 updated by: Güzin Ünlü Suvari, Istanbul University - Cerrahpasa

The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women With Preeclampsia

Preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. It is clinically characterized by elevated blood pressure (≥140/90 mmHg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and cerebral symptoms. This condition poses significant risks for both maternal and fetal health, increasing the likelihood of organ damage, preterm birth, and long-term cardiovascular and neurodevelopmental complications. Non-pharmacological interventions, including relaxation techniques, have been explored for symptom management. Progressive muscle relaxation (PMR) has shown efficacy in reducing stress, anxiety, and blood pressure. Recently, virtual reality (VR)-based relaxation techniques have gained attention for enhancing stress relief and improving health outcomes. This study aims to compare the effects of VR-based PMR with in-person PMR on maternal and fetal outcomes in preeclamptic pregnancies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
96

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)
        • Recruiting
        • Umraniye Training and Research Hospital
        • Contact:
          • Güzin Ünlü Suvari, M.Sc.

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized with a diagnosis of preeclampsia.
  • Gestational age ≥26 weeks.
  • 18 years or older.
  • Singleton and viable pregnancy.
  • Willing to participate in the study voluntarily.

Exclusion Criteria:

  • Multiple pregnancy.
  • Pregnancy achieved through assisted reproductive technologies.
  • Hearing or vision impairment in the pregnant individual.
  • Fetal distress requiring emergency intervention.
  • HELLP Syndrome or Eclampsia.
  • History of vertigo.

Withdrawal Criteria:

  • Cases where live birth does not occur.
  • Participants who voluntarily withdraw from the study.
  • Participants whose general health condition deteriorates during the intervention.
  • Participants experiencing side effects from virtual reality headset use (e.g., dizziness, nausea, headache).
  • Participants who do not practice progressive muscle relaxation at least once a week after the intervention.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG)
Participants in this group will engage in 15-minute progressive muscle relaxation (PMR) exercises guided by the researcher for three consecutive days (once per day). To promote continued practice, participants will receive an audio recording of the PMR session, narrated by the researcher. After the initial three supervised sessions, they will be asked to listen to this recording twice a week and log their practice on a provided tracking sheet. The researcher will follow up with participants via phone calls to monitor compliance.
Other: Face-to-Face Progressive Muscle Relaxation
Participants practice progressive muscle relaxation exercises in a traditional face-to-face setting, guided by a researcher. Initial supervised sessions are complemented by self-guided practice using an audio recording.
No Intervention: Control Group
Participants in the control group will not receive any relaxation intervention and will continue their usual daily routines.
Experimental: Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG)
Participants will undergo 15-minute VR-assisted PMR sessions for three consecutive days (once per day) under the researcher's supervision. During the VR sessions, participants will be exposed to relaxing nature scenes and sounds while simultaneously engaging in researcher-guided progressive muscle relaxation (PMR) exercises. After the initial three sessions, participants will receive an audio recording of the PMR session and will be instructed to listen to it twice a week, logging their sessions. The researcher will conduct phone follow-ups to ensure adherence.
Other: Virtual Reality Based Progressive Muscle Relaxation
Participants engage in progressive muscle relaxation exercises using a virtual reality headset that provides immersive visual and auditory relaxation content. Sessions are conducted under researcher supervision, followed by self-guided practice using an audio recording.

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
Descriptive Information Form
Time Frame: Day 1 (Baseline, Pre-Intervention)
A researcher-developed questionnaire designed to collect sociodemographic and obstetric data based on the literature.
Day 1 (Baseline, Pre-Intervention)
Maternal-Fetal Outcomes Follow-up Form
Time Frame: Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)
Tracked using a researcher-developed follow-up form, including maternal vital signs and Non-Stress Test (NST) parameters.
Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)
Beck Anxiety Inventory (BAI)
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Developed by Beck, Steer, Epstein, and Brown in 1988 and adapted into Turkish by Ulusoy et al. in 1998, this 21-item Likert-type scale measures anxiety levels. Each item is scored between 0 and 3, with total scores ranging from 0 to 63. Higher scores indicate higher levels of anxiety. The Turkish version has a Cronbach's alpha of 0.93, indicating high internal consistency. Factor analysis suggests two subscales: Subjective Symptoms and Somatic Symptoms.
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Prenatal Comfort Scale (PCS)
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Originally developed by Takeishi et al. in 2011 in Japan and later revised by Nakamura et al. in 2015 to a 15-item version, this scale measures prenatal comfort across five subscales: Partner's Role in Fatherhood, Fetal Interaction, Social Support, Maternal Role Adaptation, and Awareness of Pregnancy Changes. The 6-point Likert-type scale ranges from 0 (strongly disagree) to 5 (strongly agree), with higher scores indicating higher comfort levels. The scale has a Cronbach's alpha of 0.95 in the original study and 0.82 in the Turkish adaptation.
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Satisfaction Evaluation Form (VAS)
Time Frame: Day 3 (Post-Intervention)
A researcher-developed form assessing participants' overall satisfaction with the intervention, perceived anxiety and stress reduction, and general experience. (only for intervention groups)
Day 3 (Post-Intervention)
Edinburgh Postpartum Depression Scale (EPDS)
Time Frame: Up to 4-6 weeks postpartum (via phone follow-up)
eveloped by Cox et al. in 1987 and adapted into Turkish by Engindeniz et al. in 1996, this 10-item, 4-point Likert-type self-report scale assesses postpartum depression risk. Scores range from 0 to 30, with a cut-off point of 13. Internal consistency in the Turkish adaptation is 0.79, with a sensitivity of 0.84 and specificity of 0.88.
Up to 4-6 weeks postpartum (via phone follow-up)
Postpartum Evaluation Form
Time Frame: Up to 4-6 weeks postpartum (via phone follow-up)
A researcher-developed form assessing delivery type, maternal and neonatal health parameters, and newborn evaluations based on literature
Up to 4-6 weeks postpartum (via phone follow-up)
Heart Rate Variability (HRV) Measurement via Photoplethysmography (PPG)
Time Frame: Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).
A non-invasive test used to assess physiological stress levels by measuring heart rate variability (HRV) through a photoplethysmography (PPG) sensor placed on the fingertip.
Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).

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.
  • Principal Investigator: Ergül Aslan, Prof. Dr., Istanbul University-Cerrahpaşa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 8, 2025

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.
September 1, 2026

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.
September 1, 2026

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).
March 12, 2025

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.
March 18, 2025

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.
March 25, 2025

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.
June 10, 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.
June 7, 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.
June 1, 2026

More Information

Terms related to this study

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.
  • 2025-01/37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will be stored in an online database (e.g., Mendeley). Data will be available upon request after the study results are published by the researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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