Music Therapy for Labor Pain and Anxiety

University Tunis El Manar

Status: Not yet enrolling

Conditions: Labor Pain; Anxiety

Treatments: Other: Music Therapy During Labor

Study type: Interventional

Funder types: Other

Identifiers

NCT07139574

03/2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 )

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Music group

Experimental group

Description:

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.

Treatment:

Other: Music Therapy During Labor

Control Group

No Intervention group

Description:

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.