Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07139574

Music Therapy for Labor Pain and Anxiety

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ben Arous regional Hospital

Ben Arous, 2096, Tunisia

Location contact

NESRINE SOUAYEH, Associate Professor

CONTACT

[email protected]

97816168 ext. +216

Oumaima Marzouki, Master's Student

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Music Therapy During Labor

Other

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 personalized music choice, delivery timing, and structured application within labor progression monitoring.

Primary outcomes

  1. Pain level

    Time frame: 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.

  2. Anxiety level

    Time frame: 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.

Secondary outcomes

  1. Maternal pulse rate

    Time frame: 30 minutes after completing the music session

    Maternal pulse rate will be maesured in beat per minute 30 mn after listening to the musioc selection

  2. Maternal arterial pressure

    Time frame: 30 minutes after completing the music session

    Maternal arterial pressure will be maesured in mmHg

  3. Apgar score

    Time frame: 5 minutes after delivery

    the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery

  4. Maternal satisfaction

    Time frame: 2 hours after delivery

    Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery

Study contacts

Contact information is provided by the study sponsor or research team.

NESRINE SOUAYEH, Associate Professor

CONTACT

[email protected]

97816168 ext. +216

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.