| CTRI Number |
CTRI/2025/10/095580 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of music therapy on pain after cesarean section under regional anaesthesia |
|
Scientific Title of Study
|
Evaluation of the effect of music therapy on postoperative pain on patients undergoing elective lower segment cesarean section under regional anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karishma Binyala |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9650740782 |
| Fax |
|
| Email |
karishmabinyala15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Kumar |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Karishma Binyala |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9650740782 |
| Fax |
|
| Email |
karishmabinyala15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground Floor, Main
OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS) New Delhi 110029 India
|
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical college and Safdarjung hospital |
| Address |
Vardhaman Mahavir medical college and Safdarjung hospital Ansari Nagar New Delhi 110029 |
| 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 |
| Karishma Binyala |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital Ansari Nagar New Delhi 110029 India
South
DELHI |
9650740782
karishmabinyala15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: G891||Acute pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music Therapy |
Patients in the intervention group will listen to non-verbal, instrumental, non-religious music of their own choice via noise-cancelling headphones. The session will start 30 minutes before surgery, continue intraoperatively during regional anaesthesia (duration depending on surgery length), and for 30 minutes postoperatively in the recovery area, for a total duration of approximately 2–3 hours. |
| Comparator Agent |
No music (silent headphones) |
Patients in the control group will wear identical noise-cancelling headphones without music (silent) for the same total duration of approximately 2–3 hours (30 minutes preoperatively, intraoperatively during regional anaesthesia depending on surgery length, and 30 minutes postoperatively). This ensures environmental consistency and blinding with the intervention group.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA II patients undergoing elective lower segment cesarean section under regional anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with hearing impairment, psychiatric illness or anxiety disorder, patients on anxiolytics, antidepressants, or analgesics preoperatively, and patients with contraindication to regional anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative pain levels measured using Numeric Rating Scale (NRS).
|
1 hour 2 hour 4 hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative anxiety measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS) |
Preoperatively and postoperative |
| Hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure, SpO2). |
Baseline vitals after wheeling in ot, after administration of regional anaesthesia then at 10 minutes 20 minutes 30 minutes 60 minutes 90 minutes 120 minutes |
| Sedative/anxiolytic and rescue analgesic requirement (number of doses and total consumption — e.g., IV tramadol 50 mg). |
Intraoperative and upto 4 hour postoperatively |
| Patient satisfaction measured by 5-point Likert scale |
Before discharge from Post anaesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled study will evaluate the effect of music therapy on postoperative pain and perioperative anxiety in women undergoing elective lower segment cesarean section under regional anaesthesia. A total of 104 patients will be randomized into music and no-music groups. Pain (NRS), anxiety (APAIS), hemodynamics, sedative use, and patient satisfaction will be assessed to determine whether music provides a safe, cost-effective, non-pharmacological adjunct for improved perioperative outcomes. |