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Completed
NCT07669090
Effects of Virtual Reality and Relaxation During Non-Stress Testing
Conditions: Maternal Anxiety Level, Non Stress Test (NST), High Risk Pregnancy, Virtual Reality, Progressive Muscle Relaxation Exercise, Physiological Parameters
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 126
Sponsor: Istanbul University - Cerrahpasa
Location: Kanuni Sultan Suleyman Training and Research Hospital Istanbul
Summary
Aim:
This randomized controlled trial aimed to compare the effectiveness of virtual reality and progressive muscle relaxation exercise in reducing anxiety during the non-stress test (NST) and to evaluate their effects on maternal physiological parameters in high-risk pregnant women.
Materials and Methods:
The study was conducted as a randomized controlled trial between March 2025 and August 2025 at Kanuni Sultan Süleyman Training and Research Hospital with 126 high-risk pregnant women. Participants were randomly assigned to three groups (42 per group): virtual reality, progressive muscle relaxation exercise, and control group.
During NST monitoring, participants in the virtual reality group received VR headset-based immersive audiovisual stimulation, while participants in the progressive muscle relaxation group performed guided relaxation exercises. The control group received routine NST monitoring without any additional intervention.
Data were collected using the Informed Consent Form, Pregnant Woman Information Form, Non-Stress Test Follow-up Form, Physiological Parameters Follow-up Form, Visual Analog Scale (VAS), and State-Trait Anxiety Inventory (STAI Form TX-I). The STAI, VAS, and physiological parameters were measured before and after NST, while fetal NST parameters were recorded during the procedure.
Eligibility Criteria
Inclusion Criteria
Participants who meet all of the following criteria will be eligible for inclusion:
* Aged 18 years or older;
* Able to read, write, and understand Turkish;
* At ≥28 weeks of gestation;
* Having a singleton pregnancy;
* Having eaten, emptied the bladder, and refrained from smoking and alcohol consumption for at least 2 hours before the non-stress test (NST) procedure;
* Diagnosed by a physician with a high-risk pregnancy, including but not limited to preeclampsia, gestational diabetes mellitus, gestational hypertension, chronic hypertension, type 1 or type 2 diabetes mellitus, decreased fetal movement, premature rupture of membranes, threatened preterm birth, intrauterine growth restriction (IUGR), small for gestational age (SGA), oligohydramnios, or polyhydramnios.
Exclusion Criteria
Participants meeting any of the following criteria will be excluded:
* Having a physical or mental condition that may impair communication;
* Having a medical condition that may prevent participation in the intervention (e.g., musculoskeletal disorders, asthma);
* Receiving magnesium sulfate (MgSO₄) treatment or having received MgSO₄ within the previous 2 hours.
Withdrawal Criteria
Participants will be withdrawn from the study if they:
* Request to withdraw or no longer wish to continue participation in the study;
* Are assigned to an intervention group and fail to participate in at least 80% of the intervention sessions.
Source: ClinicalTrials.gov (NCT07669090). StuddyBuddy aggregates publicly available trial information.