Binaural Beat Music, Virtual Reality, and Hormones in Childbirth (VR)

April 2, 2026 updated by: Dilek Hacivelıoğlu, Medipol University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Beykoz, Istanbul, Turkey (Türkiye), 34810
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
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
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.
Other Names:
  • VR Group
Experimental: Binaural Beats-Supported Music Group
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
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.
Other Names:
  • BB Group
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor pain
Time Frame: Through study completion, an average of 1 year

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.
Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1-During childbirth 2-From onset of active labor to birth 3-At 1 minute after birth 4-At 5 minutes after birth
  1. Presence of episiotomy during childbirth: The presence of episiotomy will be assessed during childbirth and recorded as a binary outcome (yes/no) based on delivery records.
  2. Duration of labor from onset of active labor to birth: The duration of labor will be assessed as the time elapsed from the onset of the active phase of labor to birth, recorded in minutes.
  3. Newborn Apgar score at 1 minute after birth: Newborn condition will be assessed using the Apgar score at 1 minute after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition.
  4. Newborn Apgar score at 5 minutes after birth: Newborn condition will be assessed using the Apgar score at 5 minutes after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition.
1-During childbirth 2-From onset of active labor to birth 3-At 1 minute after birth 4-At 5 minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MedipolVRBB2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data has not yet been finalized. Decisions will be made after data collection and analysis are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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