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Completed

NCT Number: NCT07481643

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

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Key information

Conditions

Cesarean Section Anxiety Anxiety Disorders Behavior Breast Feeding Breastfeeding Feeding Behavior Lactation Mental Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Adnan Menderes University Hospital

Aydin, Aydın, 09010, Turkey (Türkiye)

About this study

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)].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Music listening

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. Oxytocin level

    Time frame: Postoperative day 1 and postoperative day 2

    Maternal serum oxytocin levels measured after breastfeeding in the postpartum period.

  3. Prolactin level

    Time frame: Postoperative day 1 and postoperative day 2

    Maternal serum prolactin levels measured in the postpartum period after breastfeeding.

  4. 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.

  5. Breastfeeding intensity

    Time frame: Postoperative day 1 and postoperative day 2

    Breastfeeding frequency recorded in the postpartum period.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Acronym: Breastfeeding

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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