NCT07289516

Brief Summary

This study aims to evaluate the effect of music played for women who undergo cesarean delivery on their early-stage pain, comfort, and mother-infant bonding levels. The study was conducted with 62 women who had cesarean deliveries and were hospitalized in the Obstetrics Unit of Bilecik Training and Research Hospital. Participants were randomly assigned to either an experimental group or a control group. Music in the Acemaşiran mode was played for 20 minutes twice, at the 8th and 16th postpartum hours for the experimental group, while the control group received routine midwifery/nursing care practices provided in the clinic after cesarean delivery. The study is designed to assess whether listening to music after cesarean delivery influences postoperative pain, comfort, and mother-infant bonding levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

January 29, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

painbondingcomfortmusiccesarean deliverymidwifery

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Intensity Measured by the Visual Analog Scale (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.

    Baseline (before intervention), 30 minutes after the first music session, and 30 minutes after the second music session.

  • Change in Postpartum Comfort Level Measured by the Postpartum Comfort Scale (PPCS)

    The Postpartum Comfort Scale (PPCS) is a 34-item Likert-type scale that assesses overall comfort levels of postpartum women. Each item is scored between 1 (disagree) and 4 (strongly agree), with total scores ranging from 34 to 136. Higher scores indicate higher comfort levels.

    8th and 16th postpartum hours.

  • Change in Mother-Infant Bonding Measured by the Mother-Infant Bonding Scale (MIBS)

    The Mother-Infant Bonding Scale (MIBS) is an 8-item scale measuring maternal emotional bonding toward the infant. Each item is scored from 0 to 3, with total scores ranging from 0 to 24. Higher scores indicate weaker bonding (worse outcome).

    16th postpartum hour.

Secondary Outcomes (3)

  • Change in Physical Comfort Level Measured by the Physical Comfort Subscale of the Postpartum Comfort Scale (PPCS)

    8th and 16th postpartum hours.

  • Change in Sociocultural Comfort Level Measured by the Sociocultural Comfort Subscale of the Postpartum Comfort Scale (PPCS)

    8th and 16th postpartum hours.

  • Change in Psychospiritual Comfort Level Measured by the Psychospiritual Comfort Subscale of the Postpartum Comfort Scale (PPCS)

    8th and 16th postpartum hours.

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the experimental group, women were exposed to music for 20 minutes twice, at the 8th and 16th hours postpartum. At the 8th postpartum hour, the Personal Information Form, Visual Analog Scale, Postpartum Comfort Scale, and Maternal-Infant Attachment Scale were administered. Music was played for 20 minutes, and routine midwifery care was provided. Thirty minutes after the intervention, the Visual Analog Scale was administered again. At the 16th postpartum hour, the Visual Analog Scale, routine midwifery care, and another 20-minute music session were conducted. Thirty minutes after this session, the Visual Analog Scale, Postpartum Comfort Scale, and Maternal-Infant Attachment Scale were applied.

Behavioral: Music intervention

Control Group

NO INTERVENTION

In the control group, at the 8th postpartum hour, the Personal Information Form, Visual Analog Scale, Postpartum Comfort Scale, and Maternal-Infant Attachment Scale were administered. Routine midwifery care was provided. Thirty minutes after the intervention, the Visual Analog Scale was applied again. At the 16th postpartum hour, the Visual Analog Scale and routine midwifery care were administered. Thirty minutes after this intervention, the Visual Analog Scale, Postpartum Comfort Scale, and Maternal-Infant Attachment Scale were administered.

Interventions

To play music

Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntary participants,
  • Undergoing cesarean delivery between 38-40 weeks of gestation,
  • Aged between 18-45 years,
  • Literate and fluent in Turkish,
  • Experiencing no complications during or after the cesarean procedure,
  • Having an uncomplicated pregnancy,
  • Free of chronic illnesses,
  • Without any auditory or visual impairments,
  • Without a diagnosed mental health condition,
  • Giving birth to a single, healthy, and live newborn.

You may not qualify if:

  • Individuals who do not consent to participate,
  • Those with any cognitive, sensory, or verbal impairments that hinder communication,
  • Diagnosed with any medical condition during pregnancy,
  • Experiencing postpartum complications affecting either the mother or the fetus,
  • Having a newborn admitted to the neonatal intensive care unit,
  • Experiencing chronic pain,
  • Individuals with hearing impairments,
  • Diagnosed with psychiatric or chronic illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Training and Research Hospital

Bilecik, Türkiye, 11000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pelin PALAS KARACA, Associate Professor

    Balikesir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Women in the experimental group listened to music for 20 minutes twice, at the 8th and 16th postpartum hours. Women in the control group received routine midwifery/nursing care practices provided in the clinic after cesarean delivery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Expert Midwife, Principal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

December 17, 2025

Study Start

March 15, 2023

Primary Completion

November 23, 2023

Study Completion

May 15, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations