Menu
Recruiting NCT06893510

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

No phase Interventional Pre-Eclampsia Maternal Health Relaxation Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Based Progressive Muscle Relaxation, Face-to-Face Progressive Muscle Relaxation.
Who it may be relevant to
Registry conditions: Pre-Eclampsia, Maternal Health, Relaxation, Virtual Reality. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Descriptive Information Form [Time frame: 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)]
  • 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).]
  • 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).]
  • 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).]
  • Satisfaction Evaluation Form (VAS) [Time frame: Day 3 (Post-Intervention)]
  • Edinburgh Postpartum Depression Scale (EPDS) [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Ümraniye Training and Research Hospital — Istanbul

Publications

  • Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. PMID 32443079
  • Bell IH, Nicholas J, Alvarez-Jimenez M, Thompson A, Valmaggia L. Virtual reality as a clinical tool in mental health research and practice . Dialogues Clin Neurosci. 2020 Jun;22(2):169-177. doi: 10.31887/DCNS.2020.22.2/lvalmaggia. PMID 32699517
  • Bernstein, D. A., Borkovec, T. D., & Hazlett-Stevens, H. (2000). New directions in progressive relaxation training: A guidebook for helping professionals. Praeger Publishing.
  • Chuang LL, Lin LC, Cheng PJ, Chen CH, Wu SC, Chang CL. The effectiveness of a relaxation training program for women with preterm labour on pregnancy outcomes: a controlled clinical trial. Int J Nurs Stud. 2012 Mar;49(3):257-64. doi: 10.1016/j.ijnurstu.2011.09.007. Epub 2011 Oct 2. PMID 21968280
  • Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14. PMID 34464836
  • Escobar-Bermudez A, Bejarano-Beltran MP. Experiences of women with preeclampsia in an Obstetric Intensive Care Unit in Colombia. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):166-174. doi: 10.1016/j.enfcli.2020.11.003. Epub 2021 Jan 9. English, Spanish. PMID 33436348
  • Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16. PMID 36383473
  • Ferguson C, Davidson PM, Scott PJ, Jackson D, Hickman LD. Augmented reality, virtual reality and gaming: an integral part of nursing. Contemp Nurse. 2015;51(1):1-4. doi: 10.1080/10376178.2015.1130360. Epub 2016 Jan 14. No abstract available. PMID 26678947

Identifiers

NCT: NCT06893510 · 2025-01/37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗