Authors
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Istanbul University - Cerrahpasa -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Background and RationaleNon‐stress test (NST) is a commonly used antenatal surveillance method in high‐riskpregnancies to evaluate fetal well‐being. However, the procedure may increase maternalanxiety and discomfort due to prolonged immobility and concern about fetal health.Elevated anxiety during NST may also influence maternal physiological responses.Non‐pharmacological interventions such as virtual reality (VR) and progressive musclerelaxation exercise (PMRE) are increasingly used in clinical settings to reduce anxietyand improve physiological stability. VR provides immersive multisensory distractionthrough audiovisual stimulation, while PMRE reduces sympathetic nervous system activitythrough systematic muscle tension and relaxation cycles.Although both interventions have been shown to reduce anxiety in different clinicalpopulations, limited evidence exists comparing VR and PMRE within the same randomizedcontrolled framework during NST in high‐risk pregnant women.Aim of the StudyThe primary aim of this randomized controlled trial is to determine the effect of virtualreality and progressive muscle relaxation exercise on maternal anxiety during non‐stresstesting in high‐risk pregnant women. The secondary aim is to evaluate their effects onmaternal physiological parameters and fetal non‐stress test outcomes.Study DesignThis study is a randomized controlled, parallel‐group clinical trial with three arms:virtual reality group, progressive muscle relaxation group, and control group. A total of126 high‐risk pregnant women (42 per group) will be enrolled.Randomization will be performed using a computer‐generated randomization system(Randomizer.org). The study is open‐label (no blinding).InterventionsVirtual Reality Group:Participants will wear a VR headset during the 20‐minute NST procedure and will beexposed to immersive audiovisual environments (e.g., nature scenes, ocean waves,rainfall). Participants may select preferred environments. Audio intensity will beindividually adjusted.Progressive Muscle Relaxation Exercise Group:Participants will receive guided PMRE during the 20‐minute NST. The intervention includessequential tensing and relaxing of major muscle groups while focusing on breathing andbodily sensations. Each muscle group will be tensed for approximately 10 seconds followedby a relaxation period of approximately 20 seconds.Control Group:Participants will receive standard NST care without any additional intervention.Data Collection ProceduresAll participants will complete the State‐Trait Anxiety Inventory (STAI Form TX‐I) and theVisual Analog Scale (VAS; 0‐10, where 0 = no tension and 10 = extreme tension)immediately before and after the NST procedure.Maternal physiological parameters including systolic blood pressure, diastolic bloodpressure, pulse rate, respiratory rate, and oxygen saturation will be measuredimmediately before and after NST using standard clinical devices.Fetal outcomes including fetal heart rate, fetal movements, accelerations, decelerations,and NST reactivity status will be recorded during the 20‐minute NST using standard NSTmonitoring equipment and standardized data collection forms.Demographic and obstetric characteristics will be collected using a structured personalinformation form prior to the intervention.Eligibility CriteriaInclusion Criteria: ‐ Pregnant women aged ≥18 years ‐ Gestational age ≥28 weeks ‐ Singleton pregnancy ‐ Hospitalized in the Perinatology (High‐Risk Pregnancy) Unit ‐ Undergoing routine NST ‐ Able to read, write, and understand Turkish ‐ Willing to participate and provide written informed consentExclusion Criteria: ‐ Cognitive, psychiatric, or communication disorders affecting participation ‐ Severe visual or hearing impairment ‐ Medical conditions preventing participation in VR or relaxation techniques (e.g.,musculoskeletal disorders, severe respiratory conditions such as uncontrolledasthma) ‐ Administration of magnesium sulfate (MgSO₄) within the last 2 hours prior to NST ‐ Refusal to participate in the studyRecruitmentParticipants will be recruited from the Perinatology Unit. Eligible patients will beinformed about the study, and written informed consent will be obtained prior toenrollment.Statistical AnalysisData will be analyzed using SPSS version 22.0. Normality of distribution will be assessedusing the Kolmogorov‐Smirnov test. Continuous variables will be presented as mean ±standard deviation, and categorical variables as frequency and percentage.Between‐group comparisons will be performed using one‐way ANOVA, followed by Tukeypost‐hoc tests for pairwise comparisons. Within‐group pre‐ and post‐interventioncomparisons will be analyzed using repeated measures ANOVA. Statistical significance willbe set at p < 0.05.
Epistemonikos ID: cb47bb35939bed5ade55aa11c0858b8d3bb284ae
First added on: Jun 26, 2026