| CTRI Number |
CTRI/2025/09/094317 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of music therapy on stress levels in adults undergoing planned lower limb surgery with regional anaesthesia |
|
Scientific Title of Study
|
Evaluation of the effect of music therapy on perioperative stress in patients undergoing elective lower limb surgery 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 |
SPOORTHI RAO |
| Designation |
POST GRADUATE RESIDENT DOCTOR |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia and Intensive Care, Main OT Complex,VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
South
DELHI
110029
India |
| Phone |
9113017292 |
| Fax |
|
| Email |
raospoorthi44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SPOORTHI RAO |
| Designation |
POST GRADUATE RESIDENT DOCTOR |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia and Critical Care, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS) Delhi
South
DELHI
110029
India |
| Phone |
9113017292 |
| Fax |
|
| Email |
raospoorthi44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SPOORTHI RAO |
| Designation |
POST GRADUATE RESIDENT DOCTOR |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Aneathesia and Critical Care, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
South
DELHI
110029
India |
| Phone |
9113017292 |
| Fax |
|
| Email |
raospoorthi44@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 |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital (in front of AIIMS) New Delhi |
| 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 |
| Spoorthi Rao |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Critical Care, OT 3, Main OT Complex, Delhi
South
DELHI |
9113017292
raospoorthi44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music |
Music will be administered once intraoperatively using sanitized head phones continuously from the start of the surgery till the end of the procedure. |
| Comparator Agent |
Serum Cortisol level |
Serum cortisol will be measured preoperatively that is baseline and postoperatively immediately after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those undergoing elective lower limb surgery belonging to ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Known cognitive impairment and language difficulty
Known auditory and hearing concerns
Patient on psychotropic medications
Any problem with the placement of headphones |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in perioperative stress |
Vital parameters before anaesthesia or music therapy that is baseline.
Intraoperative, every 2min for first 10minutes, every 10 minutes for the next 30 minutes and every 15 minutes till the end of the procedure
Postoperatively within 1 hour of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in sedative & anxiolytic requirement |
Every 2 minutes for the first 10 minutes
Every 10 minutes for the next 30 minutes
Every 15 minutes until the end of the procedure |
| Decrease in anxiety |
Before anaesthesia
Every 2 minutes for the 10 minutes for the next 30 minutes & then every 15 minutes until the end of the procedure |
| Decrease in delirium |
Postoperatively within 1 hour of surgery |
| Stable hemodynamic parameters |
Every 2 minutes for the first 10 minutes every 10 minutes for the next 30 minutes & every 15 minutes until the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2025 |
| 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 Applicable |
| 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 is randomised control trial to evaluate the effect of music therapy on perioperative stress in patients undergoing elective lower limb surgery under regional anaesthesia. The primary outcome being decrease in serum cortisol levels in the post operative period in patients who have recieved music therapy. Secondary outcome being stable hemodynamic parameters intraoperatively and post operatively decrease in sedative and anxiolytic requirement intraoperatively decrease in perioperative anxiety and postoperative delirium. |