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临床试验/NCT07177027
NCT07177027招募中不适用

The Effects of Breathing Exercises and Music Intervention During Labor on Pain Perception, Birth Expectations, and Birth Satisfaction in Primiparous Women: A Randomized Controlled Trial

Uşak University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Change in Pain Intensity During Labor

研究概览

简要总结

This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. This randomized controlled trial was conducted in the delivery unit of a hospital located in the Inner Aegean Region of Turkey. The study included 90 primiparous pregnant women admitted for vaginal delivery. Participants without visual, auditory, or neurological impairments were included and randomly assigned into three groups: music intervention group, breathing exercise group, and control group (n=30 in each group).

Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.

In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home.

During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music.

During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session.

In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise.

In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions.

For all participants, the durations of the first, second, and third stages of labor were recorded and compared across groups. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered.

Study data included sociodemographic information, VAS pain scores, and scores from the birth expectation and satisfaction scales.

详细描述

This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. The study was conducted in the delivery unit of a hospital in the Inner Aegean Region of Turkey and included 90 healthy primiparous pregnant women admitted for vaginal delivery. Participants who met the inclusion criteria were randomly assigned to one of three groups: music intervention group, breathing exercise group, or control group, with 30 women in each group.

Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.

In the music intervention group, participants attended childbirth preparation classes at 36 weeks of gestation, where they were introduced to 12 carefully selected music tracks. In order to determine the music pieces to be used in the study, a playlist consisting of 36 tracks with varying tempos and emotional content was created. The playlist included an equal number of slow, moderate, and fast-tempo pieces, each further divided into subcategories representing calming, neutral, and uplifting emotional tones.

The selection process involved 20 volunteer pregnant individuals who were not part of the study sample but shared similar demographic characteristics. These volunteers were asked to listen to short excerpts (30-60 seconds) of each track and to identify the 12 pieces they liked the most. Preferences were recorded either through a Likert-type rating form.

To minimize order effects, the music tracks were presented in a randomized sequence. Participants were encouraged to use headphones to reduce environmental distractions and ensure consistent audio quality.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants were included in the study if they met the following criteria:
  • Voluntary participation in the study and provision of written informed consent, Being a primiparous pregnant woman, Aged between 18 and 35 years, Gestational age between 38 and 42 weeks, Ability to read and write, No hearing impairment that would prevent listening to music, Planning to deliver vaginally, No respiratory disorders (e.g., asthma, COPD) that would interfere with breathing exercises, No obstetric complications that could affect labor progression (e.g., precipitous labor, prolonged labor), Attendance in antenatal childbirth education classes, including learning breathing exercises and listening to the music pieces planned for the intervention.
  • Not receiving any labor-inducing medications

排除标准

  • Participants were excluded if they met any of the following:
  • Withdrawal of consent or unwillingness to continue cooperation at any stage of the study, Refusal to continue with breathing exercises or music intervention during any phase of labor, Undergoing cesarean section due to medical indications despite initial plan for vaginal delivery, Gestational age outside of 38-42 weeks, Development of labor-related complications such as precipitous or prolonged labor during the study.

结局指标

主要结局

Change in Pain Intensity During Labor

时间窗: At 4 cm, 6 cm, and 8 cm cervical dilation during active labor

Measurement Tool: Visual Analog Scale (VAS), 0-10 Description: Pain intensity will be assessed before and after each intervention session (music or breathing exercises) at specified cervical dilations. In the control group, VAS will be measured at the same points without intervention. Primary Purpose: To determine the effect of music and breathing interventions on perceived pain intensity during labor.

Duration of Labor Stages

时间窗: During the first, second, and third stages of labor

The duration (in minutes) of each labor stage will be recorded and compared between the three groups (music, breathing, and control).

次要结局

  • Within 6-12 hours postpartum(Within 6-12 hours postpartum)
  • Birth Satisfaction Score(Within 6-12 hours postpartum)

研究者

发起方
Uşak University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Şeyma Çatalgöl

Dr

Uşak University

研究点 (1)

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