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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The research will be conducted with women who come to the hospital to give birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Beykoz | Istanbul | 34810 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36383473 | Result | 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. | |
| 31094789 |
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The plan for sharing individual participant data has not yet been finalized. Decisions will be made after data collection and analysis are completed.
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The randomized controlled study will consist of three groups: the virtual reality group, the binaural beats-supported music group, and the control group.
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The researcher who performs the biochemical analyses and the expert who performs the statistical analyses will not be given information about the groups.
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| 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. |
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| Through study completion, an average of 1 year |
| 1-During childbirth 2-From onset of active labor to birth 3-At 1 minute after birth 4-At 5 minutes after birth |
| 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. |
| 30073406 | 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. |
| 29389487 | 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. |
| 37205669 | 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. |
| 25999621 | 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. |
| 38865321 | 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. |
| 30174608 | 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. |
| 31549222 | 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. |