- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07669090
Effects of Virtual Reality and Relaxation During Non-Stress Testing
The Effect of Virtual Reality and Relaxation Exercise on Physiological Parameters and Anxiety During The Non Stress Test
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Background and Rationale
Non-stress test (NST) is a commonly used antenatal surveillance method in high-risk pregnancies to evaluate fetal well-being. However, the procedure may increase maternal anxiety 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 muscle relaxation exercise (PMRE) are increasingly used in clinical settings to reduce anxiety and improve physiological stability. VR provides immersive multisensory distraction through audiovisual stimulation, while PMRE reduces sympathetic nervous system activity through systematic muscle tension and relaxation cycles.
Although both interventions have been shown to reduce anxiety in different clinical populations, limited evidence exists comparing VR and PMRE within the same randomized controlled framework during NST in high-risk pregnant women.
Aim of the Study
The primary aim of this randomized controlled trial is to determine the effect of virtual reality and progressive muscle relaxation exercise on maternal anxiety during non-stress testing in high-risk pregnant women. The secondary aim is to evaluate their effects on maternal physiological parameters and fetal non-stress test outcomes.
Study Design
This study is a randomized controlled, parallel-group clinical trial with three arms: virtual reality group, progressive muscle relaxation group, and control group. A total of 126 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).
Interventions
Virtual Reality Group:
Participants will wear a VR headset during the 20-minute NST procedure and will be exposed to immersive audiovisual environments (e.g., nature scenes, ocean waves, rainfall). Participants may select preferred environments. Audio intensity will be individually adjusted.
Progressive Muscle Relaxation Exercise Group:
Participants will receive guided PMRE during the 20-minute NST. The intervention includes sequential tensing and relaxing of major muscle groups while focusing on breathing and bodily sensations. Each muscle group will be tensed for approximately 10 seconds followed by a relaxation period of approximately 20 seconds.
Control Group:
Participants will receive standard NST care without any additional intervention.
Data Collection Procedures
All participants will complete the State-Trait Anxiety Inventory (STAI Form TX-I) and the Visual 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 blood pressure, pulse rate, respiratory rate, and oxygen saturation will be measured immediately 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 NST monitoring equipment and standardized data collection forms.
Demographic and obstetric characteristics will be collected using a structured personal information form prior to the intervention.
Eligibility Criteria
Inclusion 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 consent
Exclusion 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 uncontrolled asthma)
- Administration of magnesium sulfate (MgSO₄) within the last 2 hours prior to NST
- Refusal to participate in the study
Recruitment
Participants will be recruited from the Perinatology Unit. Eligible patients will be informed about the study, and written informed consent will be obtained prior to enrollment.
Statistical Analysis
Data will be analyzed using SPSS version 22.0. Normality of distribution will be assessed using 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 Tukey post-hoc tests for pairwise comparisons. Within-group pre- and post-intervention comparisons will be analyzed using repeated measures ANOVA. Statistical significance will be set at p < 0.05.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye)
- Kanuni Sultan Suleyman Training and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Virtual Reality Group
Participants will receive virtual reality relaxation exercises using VR glasses (Virtual reality intervention)
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The participants in the virtual reality (VR) group will be provided with a VR headset during non-stress test (NST) monitoring. They will be given the opportunity to choose one video from five available options according to their preference. The options will include nature-based audiovisual content such as natural scenery with ambient sounds, sea views with water sounds, and rain imagery with rainfall sounds. Each participant will watch the selected video during the NST. The audio level will be individually adjusted to ensure comfort and clear hearing. The adjustable VR headset, with a smartphone positioned at the front, will be properly fitted to each participant. The VR intervention will be applied for 20-30 minutes during the NST.
Ostatní jména:
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Experimentální: Progressive muscle relaxation exercises group
Participants will receive progressive muscle relaxation exercises guided by audio instructions
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Participants in the progressive muscle relaxation (PMR) group will receive a guided PMR intervention during the non-stress test (NST), lasting 20-30 minutes.
The intervention will be implemented by the researcher in accordance with the guidelines recommended on the website of the Cognitive Behavioral Therapies Association.
Ostatní jména:
|
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Žádný zásah: Control
Participants will receive routine care without any study-specific intervention
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in State-Trait Anxiety Inventory (STAI Form TX-I) Score Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form TX-I).
The change in anxiety score from immediately before the 20-minute non-stress test (NST) procedure to immediately after the procedure will be compared among the virtual reality, progressive muscle relaxation, and control groups.
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Immediately before and immediately after the 20-minute NST procedure.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Visual Analog Scale (VAS) Tension Score Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal tension level will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no tension and 10 indicates extreme tension.
Changes in scores will be compared among groups.
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Immediately before and immediately after the 20-minute NST procedure.
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Change in Systolic Blood Pressure Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal systolic blood pressure will be measured immediately before and immediately after the NST procedure.
Changes in systolic blood pressure will be compared among groups.
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Immediately before and immediately after the 20-minute NST procedure.
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Change in Diastolic Blood Pressure Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal diastolic blood pressure will be measured immediately before and immediately after the NST procedure.
Changes in diastolic blood pressure will be compared among groups.
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Immediately before and immediately after the 20-minute NST procedure.
|
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Change in Maternal Pulse Rate Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal pulse rate will be measured immediately before and immediately after the NST procedure.
Changes in pulse rate will be compared among groups.
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Immediately before and immediately after the 20-minute NST procedure.
|
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Change in Respiratory Rate Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal respiratory rate will be measured immediately before and immediately after the NST procedure.
Changes in respiratory rate will be compared among groups.Change in Respiratory Rate Before and After the Non-Stress Test Procedure
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Immediately before and immediately after the 20-minute NST procedure.
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Change in Oxygen Saturation Before and After the Non-Stress Test Procedure
Časové okno: Immediately before and immediately after the 20-minute NST procedure.
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Maternal oxygen saturation will be measured immediately before and immediately after the NST procedure.
Changes in oxygen saturation values will be compared among groups.
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Immediately before and immediately after the 20-minute NST procedure.
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Number of Participants With Reactive Non-Stress Test Results
Časové okno: During the 20-minute NST procedure.
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NST reactivity status (reactive or non-reactive) will be assessed during the 20-minute NST procedure.
The number of participants with reactive NST results will be compared among groups.
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During the 20-minute NST procedure.
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Number of Fetal Movements Recorded During the Non-Stress Test Procedure
Časové okno: During the 20-minute NST procedure.
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The total number of fetal movements recorded during the NST procedure will be compared among groups.
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During the 20-minute NST procedure.
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Number of Fetal Accelerations Recorded During the Non-Stress Test Procedure
Časové okno: During the 20-minute NST procedure.
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The total number of fetal heart rate accelerations recorded during the NST procedure will be compared among groups.
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During the 20-minute NST procedure.
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Number of Fetal Decelerations Recorded During the Non-Stress Test Procedure
Časové okno: During the 20-minute NST procedure.
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The total number of fetal heart rate decelerations recorded during the NST procedure will be compared among groups.
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During the 20-minute NST procedure.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14.
- Aksoy, Y. E., Yılmaz, S. D., & Kılıç, S. (2024). *International Journal of Nursing Practice*.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024/234
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