Effect of VR and Music on Fetal Well-Being and Anxiety During Nonstress Test

Not Applicable

Completed

• Conditions: Virtual Reality; Anxiety; Pregnancy; Randomised Controlled Trial; Music

• Registration Number: NCT07082790
• Lead Sponsor: Bilecik Seyh Edebali Universitesi

Brief Summary

Music and virtual reality (VR) have been utilized in the medical field and are known to reduce anxiety and stress. However, a limited number of studies have investigated the effects of music and VR on women undergoing non-stress tests (NST). In this context, the present study aimed to determine the effects of music and VR on fetal movement, fetal heart rate, maternal physiological parameters, maternal satisfaction, and anxiety levels.

The study was conducted between June 2024 and February 2025 in the NST clinic of a training and research hospital in Bilecik, Turkey. Participants were divided into three groups: virtual reality, music, and control, with 20 pregnant women in each group. Data were collected using a personal information form, the State-Trait Anxiety Inventory, NST assessments, and a maternal parameter evaluation form.

The findings indicate that the use of VR and music during NST reduces anxiety levels in pregnant women, improves physiological parameters, and enhances satisfaction with the procedure. Notably, the decrease in anxiety levels and the positive changes in physiological parameters were more pronounced in the VR group.

The stress-reducing effects of distraction techniques such as VR and music may enhance placental blood flow, thereby positively influencing fetal movements and reactivity. However, further long-term studies are required to better understand how fetal activity is affected by emotional changes.

Detailed Description

Ethical principles were taken into consideration in the study. After the necessary arrangements were made in the data collection forms, the participants were given written and verbal explanations about the study, and their informed consent was obtained. Data collection forms were applied individually through face-to-face interviews with women who volunteered to participate in the study. A non-intervention midwife was responsible for performing NST for 20 minutes and assessing pregnant women's physiological parameters before and after NST. For pregnant women, the Personal Information Form was only administered before NST. SAI and TAI were performed before and after the NST procedure. One group of pregnant women in the intervention group was exposed to music, while the other group was exposed to virtual reality. The control group continued the routine practice. In addition, blood pressure and heart rate values of the pregnant women were measured and monitored by a midwife outside the study 5 minutes after the start of NST and after a 5-minute rest period after the end of NST. The NST assessments of the pregnant women in the group were evaluated by an obstetrician and gynecologist who was involved in the study but did not know which group the pregnant women were in.

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01
• Study First Submitted: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• gestational age ≥ 32 weeks,
• singleton pregnancy without any known fetal anomaly,
• no perinatal complications,
• age ≥ 18 years,
• nulliparous.

Exclusion Criteria

• Significant medical (cardiac, renal or neurological diseases) or mental diseases (psychosis, neurosis, addictions, etc.),
• Diagnosed by a physician as high-risk pregnancy (pregnancy-related hypertension, pre-eclampsia, eclampsia, gestational diabetes, premature rupture of membranes, large or small for gestational age, intrauterine growth retardation, polyhydramnios, oligohydramnios, threatened preterm delivery),
• have a multiple pregnancy,
• have a fetus with an anomaly,
• have fetal distress for which the physician considers emergency intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety	up to one hour	The State Anxiety Inventory (SAI) and Trait Anxiety Inventory (TAI) were used to measure the anxiety levels of pregnant women. The scale was developed by Spielberger and colleagues, and its Turkish validity and reliability were examined by. The scale consists of 40 items, 20 in the SAI scale and 20 in the TAI scale. With the state anxiety scale, it is possible to determine how the individual feels at that moment and under those conditions, and with the trait anxiety scale, it is possible to determine how the individual feels in general. The scale is a 4-point Likert type. The scale includes items consisting of direct and inverted statements. When calculating the total score, the total weighted score of the direct statements is subtracted from the total weighted score of the inverted statements. To the result obtained, 50 is added for the state anxiety scale and 35 for the trait anxiety scale. The final score obtained shows the anxiety level of the individual.
Pregnancy Parameters Assessment Form	Five minutes before the non-stress test (NST)	It is a form in which pulse rate (maternal heart rate (MHR)), estimated by pulse oximetry, is recorded before and after the NST procedure.

Secondary Outcome Measures

Name	Time	Method
Pregnancy Parameters Assessment Form	Five minutes after the non-stress test (NST)	It is a form in which pulse rate (maternal heart rate (MHR)), estimated by pulse oximetry, is recorded before and after the NST procedure.
NST Parameters Evaluation	up to one hour	The form was designed to evaluate NST results. The NST evaluation form included the fetal heart rate, acceleration, deceleration, and fetal movement counts, and the test result (reactive or non-reactive), which were monitored for at least 20 minutes.
State-Trait Anxiety	up to one hour	State Anxiety Inventory (SAI) and Trait Anxiety Inventory (TAI) were used to measure the anxiety levels of pregnant women. The scale was developed by Spielberger and colleagues, and its Turkish validity and reliability were examined by. The scale consists of 40 items, 20 in the SAI scale and 20 in the TAI scale. With the state anxiety scale, it is possible to determine how the individual feels at that moment and under those conditions, and with the trait anxiety scale, it is possible to determine how the individual feels in general. The scale is a 4-point Likert-type. The scale includes items consisting of direct and inverted statements. When calculating the total score, the total weighted score of the direct statements is subtracted from the total weighted score of the inverted statements. To the result obtained, 50 is added for the state anxiety scale and 35 for the trait anxiety scale. The final score obtained shows the anxiety level of the individual.

Trial Locations

Locations (1)

Bilecik Şeyh Edebali University; 🇹🇷 Bilecik, Turkey