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BirthVRNCT07518667

Binaural Beat Music, Virtual Reality, and Hormones in Childbirth

A study testing Virtual reality experience and Binaural Beats-Supported Music Group in people with Birth and Hormones, run by Medipol University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the effects of Binaural Beats-supported music and virtual reality experience on the levels of oxytocin, prolactin, catecholamine, endorphin, prostaglandin E and cortisol, which are hormones that play an active role in birth, using the Elisa method. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Birth, Hormones, Virtual Reality
What is being tested?
Virtual reality experience and Binaural Beats-Supported Music Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
May 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to speak Turkish and communicate verbally
  • No hearing or visual impairments
  • The pregnancy is at term (37-42 weeks of gestation) and labor has begun
  • Single fetus with cephalic presentation
  • No chronic disease
  • Not taking hormone therapy
  • Pregnant women who do not have any obstetric risks and are expected to give birth normally

Who cannot join

  • Diagnosed with risky pregnancy
  • Complications during birth
  • Those with vision and hearing problems
  • Any pharmacological pain-reducing method applied
  • Cesarean section planned
  • Those who have experienced any alternative methods for preparing for birth or managing labor pain (such as yoga, meditation, breathing exercises, hypnosis)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Beykoz, Istanbul, 34810

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Binaural Rhythm-Supported Music and Virtual Reality Experience on Labor Pain and Hormones

This study aims to investigate the effects of Binaural Beats-supported music and virtual reality experience on the levels of oxytocin, prolactin, catecholamine, endorphin, prostaglandin E and cortisol, which are hormones that play an active role in birth, using the Elisa method. Additionally, the study will examine the effects of virtual reality experience and Binaural Beats-supported music during labor on labor pain and some birth outcomes (such as the presence of an episiotomy, the onset of labor, the duration of labor, and the newborn Apgar score).The randomized controlled study will consist of three groups: a virtual reality group, a Binaural Beats-supported music group, and a control group. The research will be completed with a total of 90 people, with 30 people in each group. The research will be conducted at the Maternity Ward of Istanbul Gaziosmanpaşa Training and Research Hospital. Ethics committee approval has been received for the research. Data collection has not yet begun. An application has been made to the hospital administration for institutional permission. The research will begin once the permissions are received.

Read the detailed description

Many non-pharmacological methods are used to support women during childbirth and to ensure that the physiological course of labor is not disrupted. Music therapy, whose therapeutic effects on the body and mind have been known for centuries, has been shown in studies to reduce pain and anxiety during childbirth and provide relaxation. Virtual reality, which has been in the spotlight in recent years and has been shown to be effective in managing acute pain and anxiety, is also emerging as a promising method due to its positive effects on the pregnant woman, fetus, and birth. On the other hand, the potential benefits of Binaural Beats-which refers to the phenomenon where sounds at different frequencies presented separately to the right and left ears are perceived as a single sound-on anxiety, pain, stress, and overall well-being have become an increasingly researched topic.

Pregnant women need education, encouragement, and support to make informed decisions about using non-pharmacological alternative methods during childbirth, and healthcare professionals need to support these methods. Therefore, it is important to conduct research on this topic and ensure that the approaches implemented are evidence-based.

The investigators expect that the results of this study, which will be based on direct blood sampling from the mother and hormone (oxytocin, prolactin, catecholamine, endorphin, prostaglandin E, and cortisol) measurement during labor and the postpartum period, will provide important evidence for non-pharmacological methods that can be used in birth environments to provide relief from fear and labor pain during labor, encourage normal birth, and facilitate normal birth.

The study population will consist of all primiparous pregnant women presenting to the hospital to give birth. The study sample will consist of pregnant women who, after obtaining the necessary permissions, were admitted to the delivery room during the study period, met the inclusion criteria, and provided informed consent after receiving study information.

Randomization will be applied to the selection of women for the experimental and control groups. The random number generation method available on the random.org website will be used. All numbers will be placed in an opaque envelope, the contents of which will be hidden from view, and a healthcare professional independent of the study will randomly draw a number for each participant. Participants will be assigned to groups based on the predetermined random order. This procedure will ensure that the randomization process is impartial and confidential. All data will be collected from admission to the delivery room until the sixth hour postpartum.

Blood will not be collected specifically for this study. The hospital where the study will be conducted routinely draws blood from women before and after birth. Approximately 1 cc of blood from these routinely collected samples will be used. The collected blood will be stored at -80°C until analysis. All participants will have oxytocin, prolactin, catecholamine, endorphin, prostaglandin E, and cortisol levels measured.

Pregnant Introduction Form, Birth Follow-up Form, and Visual Comparison Scale will be used as data collection tools.

Data collection in experimental groups:

In the experimental groups, pregnant women at the beginning of the active phase will be informed about the study and will complete the Pregnancy Introduction Form after providing informed consent and verbal assent. Information regarding group-specific procedures will be provided. When dilation reaches 5 cm, pain levels will be measured using the Visual Comparison Scale. Subsequently, the appropriate intervention (VR or music) will be applied. The entire labor process will be monitored, and follow-up findings will be recorded on the Labor and Delivery Form.

  • Virtual Reality group: Before the application, participants will be introduced to virtual reality glasses and informed about the content. A virtual reality video featuring ocean and nature images will be used. The glasses will be adjusted appropriately for each participant, and all participants will watch the same video content for 30 minutes
  • Binaural Beats-Powered Music Group: Participants will be informed about Binaural Beats-powered music before the procedure. Over-ear headphones will be adjusted appropriately, and all participants will listen to music for 30 minutes.

Pain levels will be measured again using the Visual Comparison Scale at the end of the active phase.

Data collection in the control group:

In the control group, pregnant women at the beginning of the active phase will be informed about the study and will provide informed consent and verbal assent. After completing the Pregnancy Identification Form, pain levels will be measured using the Visual Comparison Scale at 5 cm dilation. No interventions other than routine care will be applied. Information regarding the labor process and follow-up findings will be recorded on the Labor Follow-up Form. At the end of the active phase, pain levels will be measured again using the Visual Comparison Scale.

Being tested
Virtual reality experience, Binaural Beats-Supported Music Group
Keywords
Birth, hormones, virtual reality, Binaural beats, music

What participants receive

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

  • Virtual reality experienceOther

    Also called VR Group

    Meta Quest 3 virtual reality glasses will be used in the study. Video content was selected from literature. Participants will be shown a virtual reality video created from nature, lake, and ocean floor images. The video content will be pre-loaded onto the device's internal memory, enabling practical use in the delivery room without requiring an internet connection.

  • Binaural Beats-Supported Music GroupOther

    Also called BB Group

    The Acemaşiran maqam was chosen for the binaural beats-supported music group, in accordance with the relevant literature. The music will be provided using binaural beats sound.

Study groups in NCT07518667
Study groupRoleWhat they receive
Virtual Reality GroupExperimentalVirtual Reality Group: You will be shown content consisting of ocean and nature images for 30 minutes with virtual reality glasses.
Receives: Other: Virtual reality experience
Binaural Beats-Supported Music GroupExperimentalBinaural Beats-Supported Music Group: Participants will listen to music over Binaural Beats sound for 30 minutes using over-ear headphones.
Receives: Other: Binaural Beats-Supported Music Group
Control GroupNo interventionControl Group: Pregnant women in the control group will not receive any treatment other than routine care in the delivery room. Only the Pregnancy Identification Form and Visual Comparison Scale will be used. Information about the labor process and follow-up findings will be recorded on the Birth Follow-up Form.

What is being measured

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

  1. Change in maternal serum hormone levels (oxytocin, prolactin, catecholamines, endorphin, prostaglandin E, and cortisol)

    Maternal serum hormone levels (oxytocin, prolactin, catecholamines, endorphin, prostaglandin E, and cortisol) will be measured using blood samples collected at the onset of the active phase of labor and at 8 hours postpartum. The primary outcome will be the change in hormone levels between these two time points.

    Measured: From onset of active labor to 8 hours postpartum (through study completion, an average of 1 year)

Secondary outcomes (1)
  1. Labor pain

    Change in labor pain intensity measured by Visual Comparison Scale (0-10) from baseline (beginning of active phase of labor) to end of active phase.

    Labor pain intensity will be assessed using the Visual Comparison Scale (range: 0 = no pain to 10 = worst possible pain) at baseline (5 cm cervical dilation) and at the end of the active phase of labor. Changes in pain scores between time points will be analyzed.

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted8 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJul 2027 (estimated)

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
Model description
The randomized controlled study will consist of three groups: the virtual reality group, the binaural beats-supported music group, and the control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518667
Sponsor's protocol ID
MedipolVRBB2025
Acronym
VR
Status last verified
Apr 2026
First submitted
12 Mar 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The plan for sharing individual participant data has not yet been finalized. Decisions will be made after data collection and analysis are completed.

Publications

  • Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.

    PubMed 36383473
  • Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.

    PubMed 31094789
  • Garcia-Argibay M, Santed MA, Reales JM. Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis. Psychol Res. 2019 Mar;83(2):357-372. doi: 10.1007/s00426-018-1066-8. Epub 2018 Aug 2.

    PubMed 30073406
  • Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.

    PubMed 29389487
  • Ingendoh RM, Posny ES, Heine A. Binaural beats to entrain the brain? A systematic review of the effects of binaural beat stimulation on brain oscillatory activity, and the implications for psychological research and intervention. PLoS One. 2023 May 19;18(5):e0286023. doi: 10.1371/journal.pone.0286023. eCollection 2023.

    PubMed 37205669
  • JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.

    PubMed 25999621
  • Massov L, Robinson B, Rodriguez-Ramirez E, Maude R. 'Giving birth on a beach': Women's experiences of using virtual reality in labour. PLoS One. 2024 Jun 12;19(6):e0304349. doi: 10.1371/journal.pone.0304349. eCollection 2024.

    PubMed 38865321
  • Napso T, Yong HEJ, Lopez-Tello J, Sferruzzi-Perri AN. The Role of Placental Hormones in Mediating Maternal Adaptations to Support Pregnancy and Lactation. Front Physiol. 2018 Aug 17;9:1091. doi: 10.3389/fphys.2018.01091. eCollection 2018.

    PubMed 30174608
  • Pasternak Y, Miller N, Asali A, Yagur Y, Weitzner O, Nimrodi M, Pasternak Y, Berkovitz A, Biron-Shental T. Does music during labor affect mode of delivery in first labor after epidural anesthesia? A prospective study. Arch Gynecol Obstet. 2019 Nov;300(5):1239-1244. doi: 10.1007/s00404-019-05310-w. Epub 2019 Sep 23.

    PubMed 31549222

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality experience and Binaural Beats-Supported Music Group in people with Birth and Hormones, run by Medipol University 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 6 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: opening soon, as of the sponsor's last update on 8 Apr 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?

This study is still under way. Results are not available in the source record yet.

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 maternal serum hormone levels (oxytocin, prolactin, catecholamines, endorphin, prostaglandin E, and cortisol) (time frame: From onset of active labor to 8 hours postpartum (through study completion, an average of 1 year)). 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 NCT07518667, which also lists 9 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 8 Apr 2026.

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