The Effect of Nada Yoga Music Therapy on Perceived Pain and Anxiety During the Labor Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This study was designed as a randomized controlled trial. Based on the power analysis (Cohen's d = 0.80, α = 0.05, power = 80%), a total of 52 pregnant women were included, with 26 participants in the intervention group and 26 in the control group. Pregnant women who met the inclusion criteria and provided written informed consent were randomly assigned to the groups using a computer-generated randomization method.
The intervention group received Nada Yoga music therapy after admission to the delivery room, and the intervention was continued until birth. The therapy consisted of music compatible with the philosophy of Nada Yoga, including relaxing melodies, mantras, and nature sounds, which were delivered via speakers placed in the labor room. The control group received standard obstetric care.
Data were collected using the Pregnant Woman Information Form, Labor Follow-up Form, Visual Analog Scale (VAS), and the Spielberger State Anxiety Inventory.
详细描述
This study was conducted as a randomized controlled trial. The sample size was determined through a power analysis based on an effect size of 0.80 (Cohen's d) obtained from a reference study, a significance level of 5% (α = 0.05), and a statistical power of 80% (1 - β = 0.80). The calculation for two independent groups indicated that a total of 52 pregnant women, with 26 participants in each group (26 in the intervention group and 26 in the control group), were required, and the study was completed with this sample size.
The study was carried out on two independent groups to evaluate the effectiveness of music therapy during the labor process. The intervention group consisted of pregnant women who received Nada Yoga music therapy, while the control group comprised pregnant women who received standard obstetric care. Pregnant women who met the inclusion criteria and voluntarily agreed to participate provided both verbal and written informed consent, after which they were randomly assigned to the intervention or control groups using a computer-generated randomization method.
Pregnant women in the intervention group received Nada Yoga music therapy after admission to the delivery room. As part of the intervention, a specially selected music playlist consistent with the philosophy of Nada Yoga-including relaxing melodies, mantras, and nature sounds known for their calming effects-was used. The music was delivered through speakers placed in the delivery room, and the intervention was continued uninterrupted from admission until birth. No music therapy was applied to the control group; these participants were followed throughout the labor process solely according to routine obstetric care protocols.
During the implementation of the study, pregnant women admitted to the labor clinic were informed about the aim, scope, and procedures of the research. Prior to the intervention, when cervical dilation reached 4-5 cm, data were collected from both groups using the Pregnant Woman Information Form, the Labor Follow-up Form, the Visual Analog Scale (VAS) for pain assessment, and the Spielberger State Anxiety Inventory.
Following the intervention, data collection was repeated in both groups at different stages of labor. Measurements were conducted during the active phase (cervical dilation of 4-7 cm) and the transition phase (cervical dilation of 8-10 cm). At these stages, the Pregnant Woman Information Form, the Labor Follow-up Form, the Visual Analog Scale (VAS), and the Spielberger State Anxiety Inventory were re-administered to assess pain and anxiety levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Due to the nature of the intervention (audible music), participants and healthcare providers could not be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having no impairment in communication skills
- •Voluntarily agreeing to participate in the study
- •Being between 37-42 weeks of gestation
- •Planning a vaginal delivery
- •Having no high-risk factors during pregnancy
- •Having a singleton pregnancy
- •Having a vertex fetal presentation
排除标准
- •Individuals with communication problems
- •Those who do not volunteer to participate in the study
- •Pregnant women before 37 weeks of gestation or after 42 weeks of gestation
- •Pregnant women with a planned cesarean delivery
- •Pregnant women with gestational diabetes, preeclampsia, or other obstetric risk factors
- •Those with multiple pregnancies
- •Those with non-vertex fetal presentations (e.g., breech, transverse)
研究组 & 干预措施
Nada Yoga music therapy
Intervention Applied to the Intervention Group
This intervention is a behavioral intervention. Participants in the experimental arm receiPregnant women in the intervention group will receive Nada Yoga music therapy after admission to the delivery room. The intervention will be implemented as follows:
Selected music: A playlist consisting of special melodies, mantras, and nature sounds compatible with the philosophy of Nada Yoga, which have been proven to have a relaxing effect on brain waves, will be used.
Duration of application: Music therapy will continue from the time of admission to the delivery room until birth occurs.
Method of application: During this period, the pregnant women will listen to the music through speakers placed in the labor room.Pregnant women in the intervention group will listen to Nada Yoga music via speakers throughout labor after admission to the delivery room, and their pain and anxiety levels will be assessed using the VAS and the State Anxiety Inventory.
干预措施: Nada Yoga music therapy (Other)
Control Group
Procedure Applied to the Control Group Pregnant women in the control group will not receive any music therapy, and standard obstetric care procedures will be followed. This group will be monitored throughout the labor process without any additional relaxing music or sound interventions.Pregnant women in the control group will receive only routine obstetric care throughout labor, without any music or additional relaxing interventions, and their pain and anxiety levels will be assessed using the VAS and the State Anxiety Inventory.
结局指标
主要结局
Primary Outcome Measure
时间窗: Before the intervention (when cervical dilatation reached 4-5 cm) and after the intervention during the active (4-7 cm) and transition (8-10 cm) phases of labor
Before the intervention, when cervical dilatation reached 4-5 cm, the following assessments were conducted in pregnant women in both groups: collection of demographic and obstetric characteristics using the Personal Information Form and Labor Follow-up Form, assessment of pain intensity using the Visual Analog Scale (VAS), and measurement of anxiety levels using the Spielberger State Anxiety Inventory.
次要结局
- Secondary Outcome Measure(Before the intervention (at 4-5 cm cervical dilatation) and after the intervention during the active (4-7 cm) and transition (8-10 cm) phases of labor)