An interventional study of Virtual reality experience and Binaural Beats-Supported Music Group in Birth, Hormones and Virtual Reality, sponsored by Medipol University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Medipol University · Not applicable, Interventional, and Supportive care
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.
Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
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: Participants will listen to music over Binaural Beats sound for 30 minutes using over-ear headphones.
Other: Binaural Beats-Supported Music 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.
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
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
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.
Time frame: From onset of active labor to 8 hours postpartum (through study completion, an average of 1 year)
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.
Time frame: Through study completion, an average of 1 year
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. 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.
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
Plan to share: Undecided — 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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