Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06893510
The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women With Preeclampsia
Led by Istanbul University - Cerrahpasa · Updated on 2025-09-24
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Preeclampsia is a serious pregnancy condition affecting 2-8% of pregnancies worldwide, marked by high blood pressure after the 20th week of pregnancy and possible complications like protein in the urine and organ issues. It poses risks to both mother and baby, including organ damage, early birth, and long-term health problems. This research compares virtual reality-based progressive muscle relaxation (PMR) with traditional face-to-face PMR to see their effects on outcomes for mothers and babies with preeclampsia. Participants are randomly assigned to one of three groups: in-person PMR, virtual reality-assisted PMR, or a control group with no relaxation intervention. Both intervention groups receive three daily 15-minute guided PMR sessions supervised by a researcher. Afterward, they practice at home twice weekly using an audio recording while tracking their sessions. The virtual reality group experiences relaxing nature scenes during PMR via a headset. The control group continues their usual care without relaxation exercises. Throughout the study, participants complete assessments including anxiety measures, comfort scales, heart rate variability via photoplethysmography, and satisfaction surveys before and after interventions. Maternal and fetal health is monitored at baseline and during follow-up days. Postpartum evaluations occur 4 to 6 weeks after birth by phone, including depression screening. Researchers also track adherence with phone calls and logs. The study aims to understand how these relaxation methods impact health during and after preeclamptic pregnancies.
CONDITIONS
Brief Title
Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Hospitalized with a diagnosis of preeclampsia
- Gestational age 26 weeks or more
- 18 years or older
- Singleton and viable pregnancy
- Willing to participate voluntarily
You will not qualify if you...
- Multiple pregnancy
- Pregnancy achieved through assisted reproductive technologies
- Hearing or vision impairment
- Fetal distress requiring emergency intervention
- HELLP Syndrome or Eclampsia
- History of vertigo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 3 days plus ongoing practice for up to 4-6 weeks postpartum
Participants engage in progressive muscle relaxation exercises either through virtual reality sessions or face-to-face guided sessions for three consecutive days, followed by self-guided practice twice a week with researcher follow-up calls.
3 daily supervised sessions plus follow-up phone calls and self-guided practice twice a week
Follow-up
Duration - Up to 4 to 6 weeks postpartum
Participants are followed up via phone calls up to 4 to 6 weeks postpartum to evaluate postpartum depression and maternal-fetal outcomes.
Phone follow-up visits up to 4 to 6 weeks postpartum
Trial Site Locations
Total: 1 location
1
Ümraniye Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
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Research Team
G
Güzin Ünlü Suvari, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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