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

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: Completed
• Conditions: Anxiety; Cesarean Section; Lactation; Breastfeeding
• Intervention / Treatment: Behavioral: Music listening; Behavioral: pozitif affirmation with music

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: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory score	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	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	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

Outcome Measure	Measure Description	Time Frame
sedation level	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	Maternal serum oxytocin levels measured after breastfeeding in the postpartum period.	Postoperative day 1 and postoperative day 2
Prolactin level	Maternal serum prolactin levels measured in the postpartum period after breastfeeding.	Postoperative day 1 and postoperative day 2
Time to first lactation	Time from delivery to the first breast milk expression recorded in the postpartum period.	Within the first 48 hours after delivery
Breastfeeding intensity	Breastfeeding frequency recorded in the postpartum period.	Postoperative day 1 and postoperative day 2

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; breastfeeding; Cesarean Section; Music Therapy; oksitosin; prolaktin; pozitif olumlamalar
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Feeding Behavior; Anxiety Disorders; Breast Feeding
• Other Study ID 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