Effect Of Lıstenıng to Musıc on Women Gıvıng Bırth By Cesarean Sectıon: Paın, Comfort And Attachment

December 14, 2025 updated by: Ebru Unal, Balikesir University

The Effect Of Music Played To Women Who Gave Birth By Cesarean Section On Pain, Comfort And Mother İnfant Bonding Level İn The Early Period

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed to evaluate the effect of music played for women undergoing cesarean section on early-stage pain, comfort, and mother-infant bonding. The study included a total of 62 women who had cesarean deliveries and were admitted to the Obstetrics and Gynecology Department of Bilecik Training and Research Hospital. Participants were randomly assigned to an experimental group (n=31) and a control group (n=31).

Data are collected using the Descriptive Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPCS), and Mother-Infant Attachment Scale (MBIS). The data will be analyzed using IBM SPSS V23 and JAMOVI V2.3.21 software.

The study is designed to compare the effects of listening to music in the Acemaşiran mode with standard postpartum care after cesarean delivery. The intervention involves listening to music for 20 minutes at the 8th and 16th postpartum hours in the experimental group, while the control group receives routine midwifery/nursing care practices.

The following hypotheses will be tested:

H1-a: Listening to music affects the pain levels of women after cesarean delivery.

H1-b: Listening to music affects the comfort levels of women after cesarean delivery.

H1-c: Listening to music affects the physical comfort levels of women after cesarean delivery.

H1-d: Listening to music affects the sociocultural comfort levels of women after cesarean delivery.

H1-e: Listening to music affects the psychospiritual comfort levels of women after cesarean delivery.

H1-f: Listening to music affects the mother-infant bonding relationship of women after cesarean delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Türkiye
      • Bilecik, Türkiye, Turkey (Türkiye), 11000
        • Bilecik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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
To play music
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
Time Frame: Baseline (before intervention), 30 minutes after the first music session, and 30 minutes after the second music session.
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)
Time Frame: 8th and 16th postpartum hours.
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)
Time Frame: 16th postpartum hour.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physical Comfort Level Measured by the Physical Comfort Subscale of the Postpartum Comfort Scale (PPCS)
Time Frame: 8th and 16th postpartum hours.
The Physical Comfort Subscale of the Postpartum Comfort Scale (PPCS) assesses physical well-being and recovery in postpartum women. Items are scored from 1 (disagree) to 4 (strongly agree), and total scores range from 10 to 40. Higher scores indicate greater physical comfort.
8th and 16th postpartum hours.
Change in Sociocultural Comfort Level Measured by the Sociocultural Comfort Subscale of the Postpartum Comfort Scale (PPCS)
Time Frame: 8th and 16th postpartum hours.
The Sociocultural Comfort Subscale of the Postpartum Comfort Scale (PPCS) evaluates the sociocultural adaptation and support experienced by postpartum women. Each item is scored from 1 to 4, and total scores range from 8 to 32. Higher scores indicate greater sociocultural comfort.
8th and 16th postpartum hours.
Change in Psychospiritual Comfort Level Measured by the Psychospiritual Comfort Subscale of the Postpartum Comfort Scale (PPCS)
Time Frame: 8th and 16th postpartum hours.
The Psychospiritual Comfort Subscale of the Postpartum Comfort Scale (PPCS) assesses emotional, spiritual, and psychological comfort in postpartum women. Each item is scored from 1 to 4, with total scores ranging from 10 to 40. Higher scores indicate greater psychospiritual comfort.
8th and 16th postpartum hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balikesir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pelin PALAS KARACA, Associate Professor, Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BU-SBE-EU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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