Impact of Music Therapy on Labor Pain and Anxiety: A Randomized Controlled Trial in Tunisian Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
This multicenter randomized controlled trial evaluates the effectiveness of music therapy in reducing pain and anxiety during the latent and active phases of labor in Tunisian women. Participants are randomized to receive either music therapy or standard care. Primary outcomes are pain (VAS) and anxiety (STAI-Y). Secondary outcomes include labor duration, maternal and fetal vital signs, neonatal outcomes, and maternal satisfaction.
详细描述
This study investigates the impact of music therapy on pain and anxiety management during labor in Tunisian parturients. Given the limited access to pharmacological analgesia in many public maternity units, the trial explores music as a non-pharmacological, low-cost, and patient-centered intervention. Eligible women in labor are randomly assigned to either a music therapy group or a control group receiving standard care. Music is administered during the latent and active phases following established clinical guidelines (slow tempo, non-lyrical, patient-guided selection). The study evaluates changes in pain intensity, anxiety levels, labor progression, maternal-fetal physiological parameters, neonatal outcomes, and maternal satisfaction. Findings aim to inform labor care practices and promote integrative approaches in resource-limited settings.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married Tunisian women with a singleton, low-risk pregnancy.
- •Admitted in the latent phase of spontaneous labor, as diagnosed by a midwife or resident.
- •Planned vaginal delivery.
- •Parity <
- •Gestational age between 37 and 41 weeks of amenorrhea.
- •Attended at least 4 prenatal consultations.
- •Normal physical and mental health status.
- •No known fetal anomalies.
- •Estimated fetal weight between 2500-4000 g.
- •Cephalic presentation.
- •Normal fetal heart rate and uterine contraction tracings.
- •Able to read, write, and understand study-related information.
- •Provided written informed consent.
排除标准
- •Women who received epidural analgesia during labor.
- •Presence of auricular malformations.
- •Difficulty in understanding or completing the VAS or STAI-Y assessments.
- •Serious medical or psychiatric disorders.
- •Multiple gestation or pregnancies requiring immediate intervention.
- •Preterm (<37 weeks) or post-term (>41 weeks) pregnancies.
- •Premature rupture of membranes.
- •Clinical chorioamnionitis or other infections (including HIV).
- •History of severe obstetric complications (e.g., cephalopelvic disproportion, intrauterine fetal death )
研究组 & 干预措施
Music group
The intervention consists of music therapy administered during the latent and active phases of labor. Music is delivered through headphones or speakers and includes slow, instrumental, non-lyrical tracks (60-80 beats per minute), selected in collaboration with the participant. The intervention is applied for a minimum duration of 30 minutes and follows established clinical guidelines for therapeutic music use. Standard monitoring of maternal and fetal well-being is maintained throughout the intervention.
干预措施: Music Therapy During Labor (Other)
Control Group
This group received routine care during labor (monitoring of labor progression, vital signs, and fetal heart rate monitoring).
No specific pain management techniques were used for this group.
结局指标
主要结局
Pain level
时间窗: 30 minutes after completing the music session
Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = worst imaginable pain.
Anxiety level
时间窗: 30 minutes after completing the music session
Anxiety level will be measured using the State-Trait Anxiety Inventory, Form Y (STAI-Y), with higher scores indicating greater anxiety.
次要结局
- Maternal pulse rate(30 minutes after completing the music session)
- Apgar score(5 minutes after delivery)
- Maternal arterial pressure(30 minutes after completing the music session)
- Maternal satisfaction(2 hours after delivery)
研究者
Nesrine Souayeh
Associate Professor
University Tunis El Manar