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Maternal Anxiety LevelNCT07669090

Effects of Virtual Reality and Relaxation During Non-Stress Testing

A study testing Virtual reality glasses and Progressive muscle relaxation exercises in people with Maternal Anxiety Level and Non Stress Test (NST), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Virtual reality glasses and Progressive muscle relaxation exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 1 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kanuni Sultan Suleyman Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Virtual reality glasses, Progressive muscle relaxation exercises
Keywords
Virtual Reality, Anxiety, Progressive Relaxation Exercise, Non-Stress Test, Physiological Parameters, Pregnancy
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality glassesBehavioural

    Also called Virtual reality

    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.

  • Progressive muscle relaxation exercisesBehavioural

    Also called Progressive muscle exercises

    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.

Study groups in NCT07669090
Study groupRoleWhat they receive
Virtual Reality GroupExperimentalParticipants will receive virtual reality relaxation exercises using VR glasses (Virtual reality intervention)
Receives: Behavioral: Virtual reality glasses
Progressive muscle relaxation exercises groupExperimentalParticipants will receive progressive muscle relaxation exercises guided by audio instructions
Receives: Behavioral: Progressive muscle relaxation exercises
ControlNo interventionParticipants will receive routine care without any study-specific intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)
  1. Change in Visual Analog Scale (VAS) Tension Score Before and After the Non-Stress Test Procedure

    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.

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

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

    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.

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

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

    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.

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

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

    Maternal pulse rate will be measured immediately before and immediately after the NST procedure. Changes in pulse rate will be compared among groups.

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

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

    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

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

  6. Change in Oxygen Saturation Before and After the Non-Stress Test Procedure

    Maternal oxygen saturation will be measured immediately before and immediately after the NST procedure. Changes in oxygen saturation values will be compared among groups.

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

  7. Number of Participants With Reactive Non-Stress Test Results

    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.

    Measured: During the 20-minute NST procedure.

  8. Number of Fetal Movements Recorded During the Non-Stress Test Procedure

    The total number of fetal movements recorded during the NST procedure will be compared among groups.

    Measured: During the 20-minute NST procedure.

  9. Number of Fetal Accelerations Recorded During the Non-Stress Test Procedure

    The total number of fetal heart rate accelerations recorded during the NST procedure will be compared among groups.

    Measured: During the 20-minute NST procedure.

  10. Number of Fetal Decelerations Recorded During the Non-Stress Test Procedure

    The total number of fetal heart rate decelerations recorded during the NST procedure will be compared among groups.

    Measured: During the 20-minute NST procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start1 Mar 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07669090
Sponsor's protocol ID
2024/234
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will not be disclosed for confidentiality reasons.

Publications

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

  • 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.

    PubMed 34464836

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality glasses and Progressive muscle relaxation exercises in people with Maternal Anxiety Level and Non Stress Test (NST), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in State-Trait Anxiety Inventory (STAI Form TX-I) Score Before and After the Non-Stress Test Procedure (time frame: Immediately before and immediately after the 20-minute NST procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07669090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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