NCT06621238

Brief Summary

The aim of this study is to examine the effects of music played to primiparous women who had a cesarean section on pain, state anxiety and breastfeeding success.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

September 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

December 12, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 23, 2024

Last Update Submit

December 7, 2024

Conditions

Labor PainAnxietyBreast FeedingPost Operative Pain

Outcome Measures

Primary Outcomes (3)

  • Postpartum Pain

    The Visual Analog Scale will be used to assess the level of cesarean pain in the postpartum period in the intervention and control groups. A minimum score of 1 and a maximum score of 10 are obtained from the scale. As the score obtained from the scale increases, it indicates that the pain also increases. After the pre-test and intervention, a change in pain and a change in the Visual Analog Scale score are expected in the intervention group.

    Within the first hour after birth

  • State Anxiety

    The state anxiety scale evaluates the degree of severity of the emotions or behaviors experienced by the individual in the situation he/she is in. The highest score that can be obtained is 80, and the lowest score is 20. As the score obtained from the scale increases, it shows that the state anxiety also increases.

    Within the first hour after birth

  • Breastfeeding Success

    The scale evaluates the success of mothers in breastfeeding their babies. The minimum score that can be obtained from the scale is 0 and the maximum score is 10, and a high score from the evaluation and diagnosis scale means that breastfeeding success is high.

    Within the first hour after birth

Study Arms (3)

Vsisual Analog scale (VAS)

EXPERIMENTAL

It will be used to measure pain in the intervention and control groups during the postpartum period.

Behavioral: Music

State anxiety scale

EXPERIMENTAL

It will be used to evaluate the mother's current anxiety status in the postpartum period.

Behavioral: Music

Breastfeedıng Success

EXPERIMENTAL

It will be used to evaluate the breastfeeding success of mothers in the experimental and control groups in the postpartum period.

Behavioral: Music

Interventions

MusicBEHAVIORAL

Listen to Music

Breastfeedıng SuccessState anxiety scaleVsisual Analog scale (VAS)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study evaluates pain, state anxiety, and mothers' breastfeeding success in the postpartum period.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caesarean section
  • Live birth

You may not qualify if:

  • Risky pregnancy
  • Twin pregnancy
  • Newborn with cleft palate, cleft lip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Education and Research Hospital

Mardin, Artuklu/Mardin, 47050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Labor PainAnxiety DisordersBreast FeedingPain, Postoperative

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersFeeding BehaviorBehaviorPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sibel ÖZTÜRK, PhD

    sibel.ozturk@atauni.edu.tr

    PRINCIPAL INVESTIGATOR

  • Ayşegül ŞAHİSN ÇELEBİ, PhD

    ascelebi@beu.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel ÖZTÜRK, PhD

CONTACT

+905357951648sblsbl0606@gmail.com

Ülkin GÜNDÜZ ARUSER, Msc

CONTACT

0531 459 21 13ulkingunduz@artuklu.edu.tr

Study Design

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

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 1, 2024

Study Start

December 7, 2024

Primary Completion

February 15, 2025

Study Completion

April 15, 2025

Last Updated

December 12, 2024

Record last verified: 2024-09

Locations

TU(1)