Music Therapy for Labor Pain and Anxiety

NCT ID: NCT07139574

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-11-30

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 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.

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.

Conditions

Labor Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music Therapy During Labor

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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 )

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Nesrine Souayeh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Arous regional Hospital

Ben Arous, , Tunisia

Countries

Tunisia

Central Contacts

NESRINE SOUAYEH, Associate Professor

Role: CONTACT

nesrine.souayeh@fmt.utm.tn

97816168 ext. +216

Facility Contacts

NESRINE SOUAYEH, Associate Professor

Role: primary

nesrine.souayeh@fmt.utm.tn

97816168 ext. +216

References

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.

Reference Type: BACKGROUND

PMID: 40346658 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33050409 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35600844 (View on PubMed)

Other Identifiers

03/2025

Identifier Type: -

Identifier Source: org_study_id