Cesarean DeliveryNCT07289516
Effect Of Lıstenıng to Musıc on Women Gıvıng Bırth By Cesarean Sectıon: Paın, Comfort And Attachment
A study testing Music intervention in people with Cesarean Delivery and Music Listening, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery, Music Listening
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Training and Research Hospital
Bilecik, Türkiye, 11000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Delivery, Music Listening
- Being tested
- Music intervention
- Keywords
- pain, bonding, comfort, music, cesarean delivery, midwifery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
To play music
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 16th postpartum hour.
Secondary outcomes (3)
Change in Physical Comfort Level Measured by the Physical Comfort Subscale of the Postpartum Comfort Scale (PPCS)
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.
Measured: 8th and 16th postpartum hours.
Change in Sociocultural Comfort Level Measured by the Sociocultural Comfort Subscale of the Postpartum Comfort Scale (PPCS)
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.
Measured: 8th and 16th postpartum hours.
Change in Psychospiritual Comfort Level Measured by the Psychospiritual Comfort Subscale of the Postpartum Comfort Scale (PPCS)
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.
Measured: 8th and 16th postpartum hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Mar 2023
- Primary completion23 Nov 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Unal, Balikesir University
- Investigators
- Pelin PALAS KARACA, Associate Professor, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289516
- Sponsor's protocol ID
- BU-SBE-EU-001
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07289516
- Acronym / sponsor ID
- BU-SBE-EU-001
- Conditions
- Cesarean Delivery, Music Listening
- Keywords
- pain, bonding, comfort, music, cesarean delivery, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Music interventionIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionTo play music | Behavioural | Experimental Group |
Primary outcome
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.
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.
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).
3 secondary outcomes
Change in Physical Comfort Level Measured by the Physical Comfort Subscale of the Postpartum Comfort Scale (PPCS)
Time frame: 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.
Change in Psychospiritual Comfort Level Measured by the Psychospiritual Comfort Subscale of the Postpartum Comfort Scale (PPCS)
Time frame: 8th and 16th postpartum hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pelin PALAS KARACA, Associate Professor principal investigator
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Cesarean Delivery and Music Listening, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.