Clinical trial NCT06893510: Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women with Preeclampsia
Official title: The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women with Preeclampsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Eclampsia
Maternal Health
Relaxation
Virtual Reality
Fetal Monitoring
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study follows a parallel-group design, where participants are randomly assigned to one of three independent groups: Face-to-Face Progressive Muscle Relaxation (F2F-PMRG), Virtual Reality Progressive Muscle Relaxation (VR-PMRG), or the Control Group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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.

Primary outcomes:
measure: Descriptive Information Form
timeFrame: Day 1 (Baseline, Pre-Intervention)
measure: 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)
measure: 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).
measure: Prenatal Comfort Scale (PCS)
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).
measure: Salivary Cortisol Test
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).
measure: Satisfaction Evaluation Form (VAS)
timeFrame: Day 3 (Post-Intervention)
measure: Edinburgh Postpartum Depression Scale (EPDS)
timeFrame: Up to 4-6 weeks postpartum (via phone follow-up)
measure: Postpartum Evaluation Form
timeFrame: Up to 4-6 weeks postpartum (via phone follow-up)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: İstanbul University-Cerrahpaşa
name: Ergül Aslan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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