Binaural Beat Music, Virtual Reality, and Hormones in Childbirth

NCT07518667 | Not Yet Recruiting DMC

• 1 other identifier: MedipolVRBB2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Birth; Hormones; Virtual Reality; Music

Keywords

Birth; hormones; virtual reality; Binaural beats; music

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Labor pain

  Through study completion, an average of 1 year

Other Outcomes (1)

• 1-Presence of episiotomy during childbirth 2-Duration of labor from onset of active labor to birth 3-Newborn Apgar score at 1 minute after birth 4-Newborn Apgar score at 5 minutes after birth

  1-During childbirth 2-From onset of active labor to birth 3-At 1 minute after birth 4-At 5 minutes after birth

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

Virtual Reality Group: You will be shown content consisting of ocean and nature images for 30 minutes with virtual reality glasses.

Other: Virtual reality experience

Binaural Beats-Supported Music Group

EXPERIMENTAL

Binaural Beats-Supported Music Group: Participants will listen to music over Binaural Beats sound for 30 minutes using over-ear headphones.

Other: Binaural Beats-Supported Music Group

Control Group

NO INTERVENTION

Control 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.

Interventions

Virtual reality experience OTHER

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.

Also known as: VR Group

Virtual Reality Group

Binaural Beats-Supported Music Group OTHER

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.

Also known as: BB Group

Binaural Beats-Supported Music Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: The research will be conducted with women who come to the hospital to give birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Beykoz, Istanbul, 34810, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 36383473 RESULT

• 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.

  PMID: 31094789 RESULT

• 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.

  PMID: 30073406 RESULT

• 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.

  PMID: 29389487 RESULT

• 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.

  PMID: 37205669 RESULT

• 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.

  PMID: 25999621 RESULT

• 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.

  PMID: 38865321 RESULT

• 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.

  PMID: 30174608 RESULT

• 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.

  PMID: 31549222 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who performs the biochemical analyses and the expert who performs the statistical analyses will not be given information about the groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: The randomized controlled study will consist of three groups: the virtual reality group, the binaural beats-supported music group, and the control group.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TU (1)