Virtual RealityNCT07082790
Effect of VR and Music on Fetal Well-Being and Anxiety During Nonstress Test
A study testing Music intervention and Virtual Reality Intervention in people with Virtual Reality and Anxiety, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Anxiety, Pregnancy
- What is being tested?
- Music intervention and Virtual Reality Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Feb 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- gestational age ≥ 32 weeks,
- singleton pregnancy without any known fetal anomaly,
- no perinatal complications,
- age ≥ 18 years,
- nulliparous.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Şeyh Edebali University
Bilecik, Bilecik, 11230
About this study
Official title: Determination of the Effect of Virtual Reality Glasses and Music Used During Non-Stress Testing on Fetal Well-Being and Anxiety in Pregnant Women
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.
Read more
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.
Read the 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.
- Conditions
- Virtual Reality, Anxiety, Pregnancy, Randomised Controlled Trial, Music
- Being tested
- Music intervention, Virtual Reality Intervention
- Keywords
- virtual reality, anxiety, pregnancy, nonstress test, music
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
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.
Virtual Reality InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music intervention |
| Control Group | No intervention | Pregnant women in the control group did not undergo any procedure and underwent routine Nonstress Test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Five minutes before the non-stress test (NST)
Secondary outcomes (4)
State-Trait Anxiety
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.
Measured: 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.
Measured: five minutes after the non-stress test (NST)
NST Parameters Evaluation
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.
Measured: up to one hour
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.
Measured: Five minutes after the non-stress test (NST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Aksoy, Bilecik Seyh Edebali Universitesi
- Investigators
- Rahime AKSOY BULGURCU, Principal investigator, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082790
- Sponsor's protocol ID
- NST-2025
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Virtual Reality Glasses and Music Used During Non-Stress Testing on Fetal Well-Being and Anxiety in Pregnant Women
- ClinicalTrials.gov ID
- NCT07082790
- Acronym / sponsor ID
- NST-2025
- Conditions
- Virtual Reality, Anxiety, Pregnancy, Randomised Controlled Trial, Music
- Keywords
- virtual reality, anxiety, pregnancy, nonstress test, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality Group | Experimental | Other: Virtual Reality InterventionPregnant 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 | Experimental | Other: Music interventionThe 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. |
| Control Group | No intervention | –Pregnant women in the control group did not undergo any procedure and underwent routine Nonstress Test. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- gestational age ≥ 32 weeks,
- singleton pregnancy without any known fetal anomaly,
- no perinatal complications,
- age ≥ 18 years,
- nulliparous.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionThe 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. | Other | Music Group |
| Virtual Reality InterventionPregnant 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 Group |
Primary outcome
State-Trait Anxiety
Time frame: 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
Time frame: Five minutes before the non-stress test (NST)
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.
Pregnancy Parameters Assessment Form
Time frame: 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.
4 secondary outcomes
State-Trait Anxiety
Time frame: up to one hour
Pregnancy Parameters Assessment Form
Time frame: five minutes after the non-stress test (NST)
NST Parameters Evaluation
Time frame: up to one hour
Pregnancy Parameters Assessment Form
Time frame: Five minutes after the non-stress test (NST)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahime AKSOY BULGURCU principal investigator
Bilecik Seyh Edebali Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and Virtual Reality Intervention in people with Virtual Reality and Anxiety, run by Bilecik Seyh Edebali Universitesi 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 5 inclusion and 5 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 24 Jul 2025. 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?
State-Trait Anxiety (time frame: up to one hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.