Status:
NOT_YET_RECRUITING
Music Therapy for Labor Pain and Anxiety
Lead Sponsor:
University Tunis El Manar
Conditions:
Labor Pain
Anxiety
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 )
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07139574
Start Date
September 1 2025
End Date
November 1 2025
Last Update
August 24 2025
Active Locations (1)
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1
Ben Arous regional Hospital
Ben Arous, Tunisia, 2096