NCT06837350

Brief Summary

The physiological effects of music therapy include creating a behavioral change and changing the mood by reducing psychophysiological stress, pain, anxiety and isolation. Music has the ability to create deep relaxation. It is known to have relieving effects on insomnia. In addition, it has been reported that music therapy application before and during birth reduces labor pain and reduces postpartum anxiety and depression levels. The postpartum period, which begins with the birth of the newborn, covers the 6-8 week period that it takes for the changes that occur in the woman's body during pregnancy to return to its pre-pregnancy state. This period is an important transition period in which physical, social and emotional changes occur in mothers. In addition to rapid anatomical and physiological changes, mothers experience a difficult process in which the transition to motherhood is experienced, new roles and responsibilities are assumed, and relationships with their spouses and other family members are reorganized. Although a woman begins to feel the changes that having a baby creates in her daily life during pregnancy, she usually experiences the biggest change after the baby is born. The period when the first emotional bond between the newborn and her family is formed and a sense of trust develops is defined as mother-baby bonding. Many factors affect mother-baby bonding in the postpartum period, which is the most important time when the bond established between the expectant mother and the baby during pregnancy, referred to as prenatal bonding, is strengthened after birth. It is particularly affected by the mother's upbringing, as well as her experiences during pregnancy, birth, puerperium, and the baby's first months. Healthy and early interaction between mother and baby initiates a healthy bonding process.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

January 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 28, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 17, 2025

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS)-pain

    Pain Level by Visual Analog Scale The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."

    On the second day after C-section and the end of the 1st week postpartum, change from first pain level an average of 20 minutes.

  • Postpartum Specific Anxiety Scale (PSAS)

    Anxiety Level by Postpartum Specific Anxiety Scale (PSAS). The VAS-anxiety is a 10 cm line used to measure perceived anxiety intensity, with endpoints labeled "No Anxiety" and "Worst Anxiety Imaginable." It meansthat those who score 73 and below on the scale have lowpostpartum anxiety levels, and those who score 101 andabove have a high level of anxiety.

    On the second day after C-section and the end of the 1st week postpartum, change from first pain level an average of 30 minutes.

  • Mother and Newborn Information Form I and I

    It will be evaluated with the Mother and Newborn Information Form I and II created by the researchers. Breastfeeding information will be assessed with this form.

    On the second day after C-section and end of the 1st postpartum week

  • Mother Infant Attachment

    It will be evaluated with the Mother-Infant Attachment Scale. The total score ranges from 0 to 24, with higher scores indicating lower mother-infant attachment.

    On the second day after C-section and end of the 1st postpartum week

Study Arms (2)

music group

EXPERIMENTAL

music group

Other: Music intervention

control group

NO INTERVENTION

control group

Interventions

Listening to Turkish Music

music group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Being in the third trimester (up to 2 weeks before the planned cesarean delivery date)
  • Being primigravida
  • Having a single fetus
  • Not having a hearing problem
  • Voluntarily participating in the study

You may not qualify if:

  • Having any chronic disease
  • Having a risky pregnancy condition (gestational diabetes, gestational hypertension, preeclampsia, etc.)
  • Having a psychiatric medical diagnosis and using medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Nuran N Aypar Akbağ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Control Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor, Obstetrics and gynecology nursing.

Study Record Dates

First Submitted

January 17, 2025

First Posted

February 20, 2025

Study Start

April 23, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 28, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Sharing is not considered appropriate until the article has completed its journal process and is published.