Binaural Beat Music, Virtual Reality, and Hormones in Childbirth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorMedipol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Diagnosed with risky pregnancy
Complications during birth
Those with vision and hearing problems
Any pharmacological pain-reducing method applied
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality experience
Other interventionMeta 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.
Binaural Beats-Supported Music Group
Other interventionThe 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Binaural Beats-Supported Music GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From onset of active labor to 8 hours postpartum (through study completion, an average of 1 year)Secondary outcomes
1
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 yearOther 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. 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 birthSponsors and contacts
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Source ClinicalTrials.gov
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