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

NCT07082790 | Completed

• 1 other identifier: NST-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Anxiety; Pregnancy; Randomised Controlled Trial; Music

Keywords

virtual reality; anxiety; pregnancy; nonstress test; music

Outcome Measures

Primary Outcomes (3)

• State-Trait Anxiety

  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.

  up to one hour

• Pregnancy Parameters Assessment Form

  It is a form in which heart rate (diastolic blood pressure (DBP) and systolic blood pressure (SBP)) is assessed by a calibrated sphygmomanometer, is recorded before and after the NST procedure.

  Five minutes before the non-stress test (NST)

• Pregnancy Parameters Assessment Form

  It is a form in which pulse rate (maternal heart rate (MHR)), estimated by pulse oximetry, is recorded before and after the NST procedure.

  Five minutes before the non-stress test (NST)

Secondary Outcomes (4)

• State-Trait Anxiety

  up to one hour

• Pregnancy Parameters Assessment Form

  five minutes after the non-stress test (NST)

• NST Parameters Evaluation

  up to one hour

• Pregnancy Parameters Assessment Form

  Five minutes after the non-stress test (NST)

Study Arms (3)

Virtual reality Group

EXPERIMENTAL

Pregnant women in the VR group were given adaptive three-dimensional (3D) glasses that fit snugly on their heads to optimize image quality and provide full distance adjustment. All pregnant women in the group were allowed to wear the glasses for a few minutes before the application in order to get used to the glasses. The image to be projected on the glasses was provided by placing a smartphone compatible with the glasses on the front of the glasses. Pregnant women in the VR group were shown an image of a green landscape with a relaxing sound accompanying the 3D images. Pregnant women in the VR group were shown an image of green nature due to the proven psychologically relaxing effect of green. Since the content in question is prepared in 360 degrees, the person wearing the glasses finds herself in the virtual world and experiences the feeling of being there, no matter which direction she looks.

Other: Virtual Reality Intervention

Music Group

EXPERIMENTAL

The music was provided to the pregnant women with wireless headphones worn over the head, an electronic acoustic device with sound-enhancing ear pads, and an adjustable headband. These headphones allowed the pregnant women to listen to music in isolation. The music played in the study was determined with the recommendation of the Research and Promotion of Turkish Music (TUMATA), which operates in Turkey and carries out treatment studies with Turkish music. Accordingly, pregnant women were made to listen to Acemashiran maqam, which is thought to have a positive effect on the uterus, the baby in the womb, and facilitate birth. According to TUMATA, Acemashiran Maqam has a fiery nature. It is a dry-hot makam. It is effective on bones and the brain. It helps balance fat in the body. It gives a sense of creativity and inspiration. Revitalizes stagnant thoughts and emotions. Facilitates childbirth in women. Helps to correct the wrong posture of the child in the womb.

Other: Music intervention

Control Group

NO INTERVENTION

Pregnant women in the control group did not undergo any procedure and underwent routine Nonstress Test.

Interventions

Music intervention OTHER

The music was provided to the pregnant women with wireless headphones worn over the head, an electronic acoustic device with sound-enhancing ear pads, and an adjustable headband. These headphones allowed the pregnant women to listen to music in isolation. The music played in the study was determined with the recommendation of the Research and Promotion of Turkish Music (TUMATA), which operates in Turkey and carries out treatment studies with Turkish music. Accordingly, pregnant women were made to listen to Acemashiran maqam, which is thought to have a positive effect on the uterus, the baby in the womb, and facilitate birth. According to TUMATA, Acemashiran Maqam has a fiery nature. It is a dry-hot makam. It is effective on bones and the brain. It helps balance fat in the body. It gives a sense of creativity and inspiration. Revitalizes stagnant thoughts and emotions. Facilitates childbirth in women. Helps to correct the wrong posture of the child in.

Music Group

Virtual Reality Intervention OTHER

Pregnant women in the VR group were given adaptive three-dimensional (3D) glasses that fit snugly on their heads to optimize image quality and provide full distance adjustment. All pregnant women in the group were allowed to wear the glasses for a few minutes before the application in order to get used to the glasses. The image to be projected on the glasses was provided by placing a smartphone compatible with the glasses on the front of the glasses. Pregnant women in the VR group were shown an image of a green landscape with a relaxing sound accompanying the 3D images. Pregnant women in the VR group were shown an image of green nature due to the proven psychologically relaxing effect of green. Since the content in question is prepared in 360 degrees, the person wearing the glasses finds herself in the virtual world and experiences the feeling of being there, no matter which direction she looks.

Virtual reality Group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Şeyh Edebali University

Bilecik, Bilecik, 11230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rahime AKSOY BULGURCU

  Bilecik Seyh Edebali Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants were divided into 3 groups (VR, music, and control). Randomization was performed via the 'Research Randomizer' (www.randomizer.org) website by a statistician from outside the study who had no previous contact with participants who met the inclusion criteria and agreed to participate in the study. This tool generated a total of 60 different codes and randomly distributed them to 3 groups. These numbers were then placed in a box, and women were assigned to a group according to the numbers they chose.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 24, 2025
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)