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

NCT ID: NCT07082790

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-02-01

Brief Summary

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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

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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.

Conditions

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Virtual Reality Anxiety Pregnancy Randomised Controlled Trial Music

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality Group

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.

Group Type EXPERIMENTAL

Virtual Reality Intervention

Intervention Type 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.

Music Group

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.

Group Type EXPERIMENTAL

Music intervention

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music intervention

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.

Intervention Type OTHER

Virtual Reality Intervention

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bilecik Seyh Edebali Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Rahime Aksoy

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahime AKSOY BULGURCU

Role: PRINCIPAL_INVESTIGATOR

Bilecik Seyh Edebali Universitesi

Locations

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Bilecik Şeyh Edebali University

Bilecik, Bilecik, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NST-2025

Identifier Type: -

Identifier Source: org_study_id

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