Music Therapy for Labor Pain and Anxiety

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Labor Pain
• Intervention / Treatment: Other: Music Therapy During Labor

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NESRINE SOUAYEH, Associate Professor; Phone Number: +216 97816168; Email: nesrine.souayeh@fmt.utm.tn

Study Locations

• Tunisia
  • Ben Arous, Tunisia, 2096
    • Ben Arous regional Hospital
    • Contact: NESRINE SOUAYEH, Associate Professor; Phone Number: +216 97816168; Email: nesrine.souayeh@fmt.utm.tn
    • Principal Investigator: Oumaima Marzouki, Master's Student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 personalized music choice, delivery timing, and structured application within labor progression monitoring.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = worst imaginable pain.	30 minutes after completing the music session
Anxiety level	Anxiety level will be measured using the State-Trait Anxiety Inventory, Form Y (STAI-Y), with higher scores indicating greater anxiety.	30 minutes after completing the music session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal pulse rate	Maternal pulse rate will be maesured in beat per minute 30 mn after listening to the musioc selection	30 minutes after completing the music session
Maternal arterial pressure	Maternal arterial pressure will be maesured in mmHg	30 minutes after completing the music session
Apgar score	the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery	5 minutes after delivery
Maternal satisfaction	Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery	2 hours after delivery

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 17, 2025
• First Submitted That Met QC Criteria: August 17, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 17, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; anxiety; music therapy; labor; pain management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Anxiety Disorders; Labor Pain
• Other Study ID Numbers: 03/2025 (Registry Identifier: EK Český Těšín)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared because of concerns regarding patient confidentiality and the absence of institutional infrastructure for secure data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No