RecruitingNot Applicable

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

Turkey (Türkiye)96 participantsStarted 2025-09-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Descriptive Information Form

Timeframe: Day 1 (Baseline, Pre-Intervention)

Maternal-Fetal Outcomes Follow-up Form

Timeframe: Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)

Beck Anxiety Inventory (BAI)

Timeframe: 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)

Heart Rate Variability (HRV) Measurement via Photoplethysmography (PPG)

Timeframe: Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).

Satisfaction Evaluation Form (VAS)

Timeframe: Day 3 (Post-Intervention)

Edinburgh Postpartum Depression Scale (EPDS)

Trial details

NCT IDNCT06893510

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Güzin Ünlü Suvari, M.Sc.

+902165004429 guzin.unlu@ogr.iuc.edu.tr

View on ClinicalTrials.gov More Pre-Eclampsia trials