Music Therapy for Labor Pain and Anxiety

NCT07139574 | Not Yet Recruiting

• 1 other identifier: 03/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Anxiety

Keywords

music therapy; anxiety; pain management; labor; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Maternal pulse rate

  30 minutes after completing the music session

• Maternal arterial pressure

  30 minutes after completing the music session

• Apgar score

  5 minutes after delivery

• Maternal satisfaction

  2 hours after delivery

Study Arms (2)

Music group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Music group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Ben Arous regional Hospital

Ben Arous, 2096, Tunisia

Location

Related Publications (3)

• 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.

  PMID: 40346658 BACKGROUND

• 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.

  PMID: 33050409 BACKGROUND

• 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.

  PMID: 35600844 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

NESRINE SOUAYEH, Associate Professor

CONTACT

97816168; nesrine.souayeh@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

TU (1)