Music Therapy for Labor Pain and Anxiety

Официальное название

Impact of Music Therapy on Labor Pain and Anxiety: A Randomized Controlled Trial in Tunisian Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Music Therapy During Labor
  This intervention involves the use of patient-selected, slow-tempo (60-80 bpm), non-lyrical instrumental music administered via headphones or speakers during the latent and active phases of labor. The music selection is guided to ensure therapeutic suitability (e.g., calming rhythm, absence of lyrics) and is delivered for a minimum of 30 minutes. The intervention is non-pharmacological, individualized, and adheres to WHO and clinical music therapy recommendations. It is distinguished by its pers

Первичные конечные точки

• Pain level [Срок оценки: 30 minutes after completing the music session]
• Anxiety level [Срок оценки: 30 minutes after completing the music session]

Вторичные конечные точки (4)

• Maternal pulse rate [Срок оценки: 30 minutes after completing the music session]
• Maternal arterial pressure [Срок оценки: 30 minutes after completing the music session]
• Apgar score [Срок оценки: 5 minutes after delivery]
• Maternal satisfaction [Срок оценки: 2 hours after delivery]

Критерии участия

Критерии включения

• 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 < 4.
• 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.

Критерии исключения

• 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 )

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Tunisia · 1 центр

• Ben Arous regional Hospital — Ben Arous

Публикации

• Vaid R, Fareed A, Farhat S, Hammoud Z, Asif MI, Ochani S, Jaber MH. Sounds of comfort: the impact of music therapy on labor pain and anxiety in primigravida women during vaginal delivery: a systematic review and meta-analysis. Reprod Health. 2025 May 9;22(1):67. doi: 10.1186/s12978-025-02023-z. PMID 40346658
• Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526. PMID 33050409
• Guo H, Que M, Shen J, Nie Q, Chen Y, Huang Q, Jin A. Effect of Music Therapy Combined with Free Position Delivery on Labor Pain and Birth Outcomes. Appl Bionics Biomech. 2022 May 11;2022:8963656. doi: 10.1155/2022/8963656. eCollection 2022. PMID 35600844

Идентификаторы

NCT: NCT07139574 · 03/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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