| CTRI Number |
CTRI/2025/02/080800 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Music on Mothers during Labor |
|
Scientific Title of Study
|
Effect of Receptive Indian Music Intervention on Pain and Anxiety among laboring mothers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr B R Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Department of Obstetrics and Gynecology & Pediatrics
Labour Room , Ground Floor, Block 2 , MCH Block Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar , Punjab
Office of the Director Principal
College Building Dr BR Ambedkar State Institute of Medical Sciences Mohali SAS Nagar Punjab
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr B R Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Office of the Director Principal, College Building , Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar , Punjab
Department of Obstetrics and Gynecology & Pediatrics
Labour Room , Ground Floor, Block 2 , MCH Block Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar , Punjab
CHANDIGARH
160012
India |
| Phone |
9914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavneet Bharti |
| Designation |
Director Principal |
| Affiliation |
Dr B R Ambedkar Institute of Medical Sciences , SAS Nagar Punjab |
| Address |
Office of Director Principal, College Building. Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar , Punjab
Department of Obstetrics and Gynecology & Pediatrics
Labour Room , Ground Floor, Block 2 , MCH Block Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar , Punjab
CHANDIGARH
160012
India |
| Phone |
9914208327 |
| Fax |
|
| Email |
bhavneetsahul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BR Ambedkar State Institute of Medical Sciences , Sector 56, Sahibzada Ajit Singh Nagar Mohali -160055, Punjab |
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Dr BR Ambedkar State Institute of Medical Sciences , Mohali SAS Nagar 160055 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavneet Bharti |
Dr BR Ambedkar State Institute of Medical Sciences |
Labour Room , Block 2 MCH division ,Phase 6 ,Mohali SAS Nagar Punjab
Rupnagar
PUNJAB |
09914208327
bhavneetsahul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHRAIMSMOHALI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Receptive Music Therapy |
Participants will listen to Indian classical instrumental music, primarily raga-based compositions, via headphones.
The music will be played continuously for a maximum of 15-30 minutes with breaks allowed upon request.
Volume will be Adjusted to the comfort level of the participant.
A trained music therapist will administer the intervention
Depending upon the patient’s mood & Raag mood, trained music therapist will deliver the music Hindi or Punjabi or devotional etc.
For example:
Raag Darbari if sad
Raag Desh Devotional
Raag Khamaj Happy and Joy
Raag Bahar Love and Romance
Raag Gaud Sarang Happiness
Patients listen to recorded music using head phones to promote relaxation or emotional release.
|
| Comparator Agent |
Standard of Care without Music Therapy |
Regular Monitoring of the pregnant laboring patients including Fetal Heart rate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Level Measured using the Visual Analog Scale VAS for pain at baseline before intervention and after the intervention
Anxiety Level Measured using the Subjective Units of Distress Scale SUDS at baseline and after the intervention |
After at least 30 mins of music intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First hour breast feeding |
within one hour of birth |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
16/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
In process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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). |