Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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
This trial does not accept healthy volunteersQualifiers
Hospitalized with a diagnosis of preeclampsia.
Gestational age ≥26 weeks.
18 years or older.
Singleton and viable pregnancy.
Disqualifiers
Multiple pregnancy.
Pregnancy achieved through assisted reproductive technologies.
Hearing or vision impairment in the pregnant individual.
Fetal distress requiring emergency intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Based Progressive Muscle Relaxation
Other interventionParticipants 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.
Face-to-Face Progressive Muscle Relaxation
Other interventionParticipants 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.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG)Experimental treatment 1 intervention
Group B: Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG)Experimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Descriptive Information Form
A researcher-developed questionnaire designed to collect sociodemographic and obstetric data based on the literature.
Time frame
Day 1 (Baseline, Pre-Intervention)2
Maternal-Fetal Outcomes Follow-up Form
Tracked using a researcher-developed follow-up form, including maternal vital signs and Non-Stress Test (NST) parameters.
Time frame
Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)3
Beck Anxiety Inventory (BAI)
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.
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).4
Prenatal Comfort Scale (PCS)
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.
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).Sponsors and contacts
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Source ClinicalTrials.gov