Effects of Virtual Reality and Relaxation During Non-Stress Testing

NCT07669090 | Completed DMC

• 1 other identifier: 2024/234
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Anxiety Level; Non Stress Test (NST); High Risk Pregnancy; Virtual Reality; Physiological Parameters; Progressive Muscle Relaxation Exercise

Keywords

Virtual Reality, Anxiety, Progressive Relaxation Exercise, Non-Stress Test, Physiological Parameters, Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in State-Trait Anxiety Inventory (STAI Form TX-I) Score Before and After the Non-Stress Test Procedure

  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.

  Immediately before and immediately after the 20-minute NST procedure.

Secondary Outcomes (10)

• Change in Visual Analog Scale (VAS) Tension Score Before and After the Non-Stress Test Procedure

  Immediately before and immediately after the 20-minute NST procedure.

• Change in Systolic Blood Pressure Before and After the Non-Stress Test Procedure

  Immediately before and immediately after the 20-minute NST procedure.

• Change in Diastolic Blood Pressure Before and After the Non-Stress Test Procedure

  Immediately before and immediately after the 20-minute NST procedure.

• Change in Maternal Pulse Rate Before and After the Non-Stress Test Procedure

  Immediately before and immediately after the 20-minute NST procedure.

• Change in Respiratory Rate Before and After the Non-Stress Test Procedure

  Immediately before and immediately after the 20-minute NST procedure.

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

Participants will receive virtual reality relaxation exercises using VR glasses (Virtual reality intervention)

Behavioral: Virtual reality glasses

Progressive muscle relaxation exercises group

EXPERIMENTAL

Participants will receive progressive muscle relaxation exercises guided by audio instructions

Behavioral: Progressive muscle relaxation exercises

Control

NO INTERVENTION

Participants will receive routine care without any study-specific intervention

Interventions

Virtual reality glasses BEHAVIORAL

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.

Also known as: Virtual reality

Virtual Reality Group

Progressive muscle relaxation exercises BEHAVIORAL

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.

Also known as: Progressive muscle exercises

Progressive muscle relaxation exercises group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: High risk pregnant woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Kanuni Sultan Suleyman Training and Research Hospital: collaborator

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Aksoy, Y. E., Yılmaz, S. D., & Kılıç, S. (2024). *International Journal of Nursing Practice*.

  BACKGROUND

• 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.

  PMID: 34464836 BACKGROUND

Related Links

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Midwife

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)