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Clinical Trials/CTRI/2025/02/080800
CTRI/2025/02/080800RecruitingPhase 2

Effect of Receptive Indian Music Intervention on Pain and Anxiety among laboring mothers

Self funded1 site in 1 country100 target enrollmentStarted: March 3, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Pain Level Measured using the Visual Analog Scale VAS for pain at baseline before intervention and after the intervention

Study Overview

Brief Summary

Labor pain and anxiety are prevalent during childbirth and can have significant effects on both maternal and fetal outcomes (1). While pharmacological interventions are widely used, there is growing interest in non-pharmacological approaches such as music therapy (2). Music has been shown to reduce anxiety and pain in various clinical settings (3), and its calming effects could be especially beneficial during labor. Indian music, known for its rhythmic and soothing characteristics, could offer a culturally relevant therapeutic tool for pain and anxiety management in laboring mothers (4). However, limited research exists regarding Indian music and its specific impact on laboring women, thus necessitating this investigation (5, 6).

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Singleton Pregnancy with Cephalic Presentation Pregnant Female in active labour Age 18 to 40 years Ability to understand the Trial Procedure and Gives Informed Consent.

Exclusion Criteria

  • High-risk pregnancies Patient having non reassuring Fetal heart rate on Cardiotocography History of psychiatric illness or diagnosed anxiety disorders Hearing impairments or conditions making it difficult to listen to music Use of any pain relieving medications or other interventions during the trial.

Outcomes

Primary Outcomes

Pain Level Measured using the Visual Analog Scale VAS for pain at baseline before intervention and after the intervention

Time Frame: After at least 30 mins of music intervention

Anxiety Level Measured using the Subjective Units of Distress Scale SUDS at baseline and after the intervention

Time Frame: After at least 30 mins of music intervention

Secondary Outcomes

  • First hour breast feeding(within one hour of birth)

Investigators

Sponsor
Self funded
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Bhavneet Bharti

Dr B R Ambedkar Institute of Medical Sciences , SAS Nagar Punjab

Study Sites (1)

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