Binaural Beat Music, Virtual Reality, and Hormones in Childbirth

Official title

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

Overview

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.

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.

Interventions

• 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 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.

Primary outcome measures

• 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)]

Secondary outcome measures (1)

• Labor pain [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University — Beykoz

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30174608

Identifiers

NCT: NCT07518667 · MedipolVRBB2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗