Fetal Monitoring, Maternal Health, Pre-Eclampsia, Relaxation, Virtual Reality
Conditions
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.
Interventions
OTHERVirtual 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.
OTHERFace-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.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
This study employs a single-blind design, where participants will be unaware of their assigned intervention group (VR-based progressive muscle relaxation or in-person progressive muscle relaxation). However, researcher administering the interventions will be informed of group assignments. To ensure ethical compliance, separate informed consent forms have been prepared for each group, detailing the intervention.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Information Form | Day 1 (Baseline, Pre-Intervention) | A researcher-developed questionnaire designed to collect sociodemographic and obstetric data based on the literature. |
| Maternal-Fetal Outcomes Follow-up Form | 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. |
| Beck Anxiety Inventory (BAI) | 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. |
| Prenatal Comfort Scale (PCS) | 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. |
| Heart Rate Variability (HRV) Measurement via Photoplethysmography (PPG) | 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. |
| Satisfaction Evaluation Form (VAS) | 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) |
| Edinburgh Postpartum Depression Scale (EPDS) | 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. |
| Postpartum Evaluation Form | 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 |
Countries
Turkey (Türkiye)
Contacts
CONTACTGüzin Ünlü Suvari, M.Sc.
PRINCIPAL_INVESTIGATORErgül Aslan, Prof. Dr.
İstanbul University-Cerrahpaşa
Outcome results
None listed