| CTRI Number |
CTRI/2025/02/080292 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Music] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if listening to music can reduce pain in patients after brain surgery |
|
Scientific Title of Study
|
Efficacy of patient preferred music therapy as an adjuvant on the post operative pain and the requirement of analgesics among the patients who have undergone transcranial neurosurgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopikrishnan R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Neurosurgery office,
Second floor,SSB.
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894309511 |
| Fax |
|
| Email |
gopikrishnancmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopikrishnan R |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Neurosurgery office,
Second floor,SSB.
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894309511 |
| Fax |
|
| Email |
gopikrishnancmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VV Anuraag Veeramachaneni |
| Designation |
MBBS |
| Affiliation |
JIPMER |
| Address |
Neurosurgery Office,
Second floor,SSB
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8867034974 |
| Fax |
|
| Email |
anuraagveeramachaneni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry-605006.
India |
|
|
Primary Sponsor
|
| Name |
Gopikrishnan R |
| Address |
Neurosurgery office,
Second floor, SSB,
JIPMER,Puducherry |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| VV Anuraag Veeramachaneni |
Jawaharlal institute of postgraduate medical education and research |
Neurosurgery Office,
Second Floor,SSB
JIPMER
Pondicherry
PONDICHERRY |
8867034974
anuraagveeramachaneni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Interventional Studies-JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music |
Patients listens to music of her/his choice for half an hour three times a day in the first four postoperative days |
| Comparator Agent |
No treatment |
No music is provided in the first four post operative days-4 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective cranial neurosurgery above the age of 18 |
|
| ExclusionCriteria |
| Details |
1.Patients who are intubated
2.Patients with a GCS of less than 15 after extubation or anytime during the postoperative period
3.Patients with hearing impairment |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of pain |
Post operative day one through four-4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dose of analgesic requirement |
Post operative day one through four-4 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
|