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

NCT07481643 | Completed

• 2 other identifiers: 2023234TPF-24007
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Cesarean Section; Breastfeeding; Lactation

Keywords

oksitosin; prolaktin; pozitif olumlamalar; breastfeeding; Music Therapy; Anxiety; Cesarean Section

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• sedation level

  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

  Postoperative day 1 and postoperative day 2

• Prolactin level

  Postoperative day 1 and postoperative day 2

• Time to first lactation

  Within the first 48 hours after delivery

• Breastfeeding intensity

  Postoperative day 1 and postoperative day 2

Study Arms (3)

Arm Title: Music Only

EXPERIMENTAL

Patients listen to classical music for 30 minutes before and during the cesarean section.

Behavioral: Music listening

Arm Title: Music with Positive Affirmations

EXPERIMENTAL

Patients listen to classical music accompanied by positive affirmations during the perioperative period.

Behavioral: pozitif affirmation with music

Control

NO INTERVENTION

Participants in the control group received standard perioperative care without music or positive affirmations during the cesarean section.

Interventions

pozitif affirmation with music BEHAVIORAL

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.

Arm Title: Music with Positive Affirmations

Music listening BEHAVIORAL

Participants listened to classical music for approximately 30 minutes during the perioperative period of cesarean section.

Arm Title: Music Only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only pregnant women scheduled for elective cesarean section are eligible to participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University Hospital

Aydin, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Mental Disorders; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: This study is a prospective randomized parallel-group trial including three groups: music with positive affirmations, music only, and a control group receiving no intervention. Participants are randomly assigned to one of the three groups and outcomes are compared between groups.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 19, 2026
• Study Start: August 22, 2024
• Primary Completion: February 5, 2025
• Study Completion: June 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)