NCT06837337

Brief Summary

Nurses and midwives stand at the forefront during childbirth; their expertise in using natural pain relief techniques not only lessens the sensation of labor pain but also helps in calming the nerves of expectant mothers. These techniques are not only safe and easy to use but also kind on the pocket and devoid of any adverse effects. Such methods can make childbirth experiences as positive and comfortable as possible. Research has delved deeper into how music shaped by cultural tastes can significantly affect individuals, leading to a closer examination of how Turkish tunes influence discomfort and nervousness during labor. The goal of this research was to explore how Turkish melodies impact pain and anxiety feelings among women going through childbirth for the first time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
8 months until next milestone

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
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

January 17, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Nursing Carieschildbirth painmusicanxiety

Outcome Measures

Primary Outcomes (3)

  • Angle Labor Pain Questionnaire

    Pain Level by Angle Labor Pain Questionnaire.

    Approximately one hour after admission to the delivery room, change from the initial pain level in 30 minutes. Scores of Angle Labor Pain Questionnaire ranged from 0 to 220, with higher values indicating greater pain intensity.

  • Visual Analog Scale (VAS)

    Pain Level by Visual Analog Scale (VAS)

    Approximately one hour after admission to the delivery room, change from the initial pain level in 30 minutes. VAS is a 10 cm line used to measure perceived pain intensity, with endpoints labeled "No Pain" and "Worst Pain Imaginable."

  • The State Anxiety Scale (SAS)

    The State Anxiety Scale (SAS) measures anxiety as a temporary emotional state.

    Approximately one hour after admission to the delivery room, change from the initial anxiety level in 30 minutes. The total scores range from 20 to 80, with higher scores indicating greater anxiety.

Study Arms (2)

music group

EXPERIMENTAL
Other: Music intervention

control group

NO INTERVENTION

Interventions

Music intervention

music group

Eligibility Criteria

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

You may qualify if:

  • primigravida women with term pregnancies (38-40 weeks) in the early active phase of labor
  • cervical dilatation between 4 and 6 cm

You may not qualify if:

  • Women who used narcotic analgesics or sedatives during labor
  • listened to music during childbirth
  • underwent induction
  • delivered via cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Turkey (Türkiye)

Location

Related Publications (1)

  • Guo H, Que M, Shen J, Nie Q, Chen Y, Huang Q, Jin A. Effect of Music Therapy Combined with Free Position Delivery on Labor Pain and Birth Outcomes. Appl Bionics Biomech. 2022 May 11;2022:8963656. doi: 10.1155/2022/8963656. eCollection 2022.

    PMID: 35600844BACKGROUND

MeSH Terms

Conditions

PainAnxiety DisordersLabor Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

February 20, 2025

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 30, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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

Locations