NCT07177027

Brief Summary

This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. This randomized controlled trial was conducted in the delivery unit of a hospital located in the Inner Aegean Region of Turkey. The study included 90 primiparous pregnant women admitted for vaginal delivery. Participants without visual, auditory, or neurological impairments were included and randomly assigned into three groups: music intervention group, breathing exercise group, and control group (n=30 in each group). Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment. In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home. During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music. During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session. In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise. In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions. For all participants, the durations of the first, second, and third stages of labor were recorded and compared across groups. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered. Study data included sociodemographic information, VAS pain scores, and scores from the birth expectation and satisfaction scales.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 9, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Music interventionBreathing exercisesBirthPregnancy

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Intensity During Labor

    Measurement Tool: Visual Analog Scale (VAS), 0-10 Description: Pain intensity will be assessed before and after each intervention session (music or breathing exercises) at specified cervical dilations. In the control group, VAS will be measured at the same points without intervention. Primary Purpose: To determine the effect of music and breathing interventions on perceived pain intensity during labor.

    At 4 cm, 6 cm, and 8 cm cervical dilation during active labor

  • Duration of Labor Stages

    The duration (in minutes) of each labor stage will be recorded and compared between the three groups (music, breathing, and control).

    During the first, second, and third stages of labor

Secondary Outcomes (2)

  • Within 6-12 hours postpartum

    Within 6-12 hours postpartum

  • Birth Satisfaction Score

    Within 6-12 hours postpartum

Study Arms (3)

Music intervention group

EXPERIMENTAL

In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home. During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music. During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered.

Behavioral: Music intervention

Breathing Exercises Group

EXPERIMENTAL

In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise.

Behavioral: Breathing Exercise

Control Group

NO INTERVENTION

In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered.

Interventions

Participants listened to 12 relaxing music tracks introduced during prenatal childbirth classes at 36 weeks of gestation. The tracks were shared via WhatsApp to encourage regular listening during pregnancy. During labor, participants were encouraged to listen to music whenever they wished. At cervical dilations of 4 cm, 6 cm, and 8 cm, participants listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured before and after each session using the Visual Analog Scale (VAS).

Music intervention group

Participants were trained in Lamaze breathing techniques during prenatal childbirth classes. They practiced guided breathing exercises during labor at cervical dilation points of 4 cm, 6 cm, and 8 cm. Pain intensity was assessed before and after each session using the Visual Analog Scale (VAS).

Breathing Exercises Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntary participation in the study and provision of written informed consent, Being a primiparous pregnant woman, Aged between 18 and 35 years, Gestational age between 38 and 42 weeks, Ability to read and write, No hearing impairment that would prevent listening to music, Planning to deliver vaginally, No respiratory disorders (e.g., asthma, COPD) that would interfere with breathing exercises, No obstetric complications that could affect labor progression (e.g., precipitous labor, prolonged labor), Attendance in antenatal childbirth education classes, including learning breathing exercises and listening to the music pieces planned for the intervention.
  • Not receiving any labor-inducing medications

You may not qualify if:

  • Withdrawal of consent or unwillingness to continue cooperation at any stage of the study, Refusal to continue with breathing exercises or music intervention during any phase of labor, Undergoing cesarean section due to medical indications despite initial plan for vaginal delivery, Gestational age outside of 38-42 weeks, Development of labor-related complications such as precipitous or prolonged labor during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak University

Uşak, Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Şeyma ÇATALGÖL, Dr

    Uşak University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şeyma ÇATALGÖL, Dr

CONTACT

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
Dr

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

December 3, 2024

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations