Evaluation Of The Effect Of Affirmations During Cesarean Section Accompanying By Musıc On Breastfeeding (Breastfeeding)

March 16, 2026 updated by: Vesile kıyıkcı Taşkoparan, Aydin Adnan Menderes University
In pregnant women, non-pharmacological methods such as music, massage, yoga, meditation, relaxation breathing exercises, and acupuncture have been tried to reduce anxiety during childbirth, and there are studies on these in the literature. However, researchers have not come across a study in the literature that evaluates the effect of positive affirmations on perioperative maternal anxiety and breastfeeding together. Researchers aim is to evaluate the relationship between anxiety, sedation, and breastfeeding levels in pregnant women who underwent positive affirmations and music therapy during cesarean section.

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

The study was designed as a prospective randomized study. Patients were randomly assigned to groups using computer-assisted methods. Clinical study registration was completed after obtaining approval number 2023/234 from the Non-Interventional Ethics Committee of Adnan Menderes University Hospital. Pregnant women undergoing cesarean section were divided into three groups: Group 1 received pre-operative affirmations accompanied by music, Group 2 received only music, and the control group (Group 3) received neither music nor affirmations. After the operation, all three groups were assessed using the State-Trait Anxiety Scale (STAI), Hospital Anxiety and Depression Scale (HADS), and Visual Analog Scale-Anxiety (VAS-A) for anxiety level tests. Patient status index, hormones (prolactin, oxytocin), time to first milk production, and breastfeeding intensity were compared. Breastfeeding intensity was calculated as [weekly number of breastfeeding sessions / (weekly number of breastfeeding sessions + formula feeding sessions)].

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.
99

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)
    • Aydın
      • Aydin, Aydın, Turkey (Türkiye), 09010
        • Aydin Adnan Menderes University 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:

  • Pregnant women aged 18-45 years
  • ASA physical status I-II
  • Scheduled for elective cesarean section under regional anesthesia
  • Ability to understand and complete the anxiety questionnaires
  • Provided written informed consent

Exclusion Criteria:

  • Refusal to participate in the study
  • Hearing impairment preventing music listening
  • Psychiatric disorders affecting anxiety assessment
  • Emergency cesarean section
  • Known endocrine disorders affecting prolactin or oxytocin levels
  • İnability to communicate or complete the questionnaires

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Arm Title: Music Only
Patients listen to classical music for 30 minutes before and during the cesarean section.
Behavioral: Music listening
Participants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section.
Experimental: Arm Title: Music with Positive Affirmations
Patients listen to classical music accompanied by positive affirmations during the perioperative period.
Behavioral: pozitif affirmation with music
Participants listened to classical music accompanied by positive affirmations for approximately 30 minutes during the perioperative period of cesarean section in order to reduce maternal anxiety and improve breastfeeding outcomes.
No Intervention: Control
Participants in the control group received standard perioperative care without music or positive affirmations during the cesarean section.

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
State-Trait Anxiety Inventory score
Time Frame: Baseline (preoperative ward assessment), after 30-minute intervention before surgery, and postoperative recovery unit (within 1 hour after cesarean section)
Maternal anxiety level assessed using the State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Baseline (preoperative ward assessment), after 30-minute intervention before surgery, and postoperative recovery unit (within 1 hour after cesarean section)
Hospital Anxiety and Depression Scale - Anxiety subscale
Time Frame: Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery).
Maternal anxiety level measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery).
Visual Analog Scale for Anxiety
Time Frame: Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery).
Maternal anxiety assessed using a Visual Analog Scale ranging from 0 to 10, where higher scores indicate greater anxiety.
Baseline (preoperative), after intervention (30 minutes before surgery), and postoperative period (within 1 hour after cesarean delivery).

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
sedation level
Time Frame: Baseline (preoperative ward assessment), after the 30-minute intervention before surgery, and in the postoperative recovery unit within 1 hour after cesarean section.
Sedation level assessed using the Patient State Index (PSI) recorded during the perioperative period.
Baseline (preoperative ward assessment), after the 30-minute intervention before surgery, and in the postoperative recovery unit within 1 hour after cesarean section.
Oxytocin level
Time Frame: Postoperative day 1 and postoperative day 2
Maternal serum oxytocin levels measured after breastfeeding in the postpartum period.
Postoperative day 1 and postoperative day 2
Prolactin level
Time Frame: Postoperative day 1 and postoperative day 2
Maternal serum prolactin levels measured in the postpartum period after breastfeeding.
Postoperative day 1 and postoperative day 2
Time to first lactation
Time Frame: Within the first 48 hours after delivery
Time from delivery to the first breast milk expression recorded in the postpartum period.
Within the first 48 hours after delivery
Breastfeeding intensity
Time Frame: Postoperative day 1 and postoperative day 2
Breastfeeding frequency recorded in the postpartum period.
Postoperative day 1 and postoperative day 2

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.
Aydin Adnan Menderes 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.
August 22, 2024

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.
February 5, 2025

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.
June 30, 2025

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).
March 5, 2026

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.
March 16, 2026

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.
March 19, 2026

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.
March 19, 2026

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.
March 16, 2026

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.
March 1, 2026

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.
  • 2023234
  • TPF-24007 (Other Grant/Funding Number: Aydin Adnan Menderes University BAP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data collected during the study, including demographic data, anxiety scores, sedation levels, and breastfeeding outcomes, will be available upon reasonable request from the corresponding investigator after publication of the study results.

IPD Sharing Time Frame

Deidentified individual participant data will be available beginning 6 months after publication of the study results and will remain available for 5 years upon reasonable request to the corresponding investigator.

IPD Sharing Access Criteria

Qualified researchers may request access to deidentified individual participant data for scientific purposes. Access will be granted upon reasonable request to the corresponding investigator and after approval of a research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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