CTRI Number |
CTRI/2016/09/007281 [Registered on: 16/09/2016] Trial Registered Retrospectively |
Last Modified On: |
24/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Music therapy] |
Study Design |
Other |
Public Title of Study
|
Effect of music therapy on pain,anxiety and opioid demand during burn dressing change. |
Scientific Title of Study
|
A study to assess the effect of music therapy on anxiety,pain perception and opioid demand at the time of dressing change among burn patients admitted in Burn Unit,Nehru Hospital, PGIMER, Chandigarh, 2014-16. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Latika Rohilla |
Designation |
Msc nursing student |
Affiliation |
PGIMER |
Address |
Medical surgical nurisng department, National institute of nursing education, PGIMER,sector-12,Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
7696809006 |
Fax |
|
Email |
anoop.rohilla85@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Meenakshi Agnihotri |
Designation |
Clinical instructor |
Affiliation |
PGIMER |
Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,sector-12,Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
987-288-5336 |
Fax |
|
Email |
smrishima@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Latika Rohilla |
Designation |
Msc nursing student |
Affiliation |
PGIMER |
Address |
Medical surgical nursing department, national institute of nursing education PGIMER,sector-12,Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
7696809006 |
Fax |
|
Email |
anoop.rohilla85@gmail.com |
|
Source of Monetary or Material Support
|
Department of plastic surgery,
PGIMER, f block, second floor, Nehru hospital, PGIMER, sector 12,
Chandigarh |
|
Primary Sponsor
|
Name |
Department of Plastic SurgeryPGIMER |
Address |
F block 2nd floor, Nehru Hospital, PGIMER sector 12 Chandigarh |
Type of Sponsor |
Research institution and hospital |
|
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 Sukhpal Kaur |
PGIMER |
Burn unit, plastic surgery ward, Nehru hospital
PGIMER
Chandigarh Chandigarh CHANDIGARH |
9888536964
swatirohilla.19@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute ethics committee,PGIMER |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Burn patients admitted in the Burn Unit, Nehru Hospital, PGIMER Chandigarh, (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Music therapy |
Instrumental music pieces as per patient choice out of the few music pieces prefixed by the researcher.
Including spiritual music, classical Indian, western and Bollywood music. Music was played half an hour before to half an after dressing |
Comparator Agent |
Nil |
Patients received routine care as per the unit protocol. |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Burn patients who are oriented to time,place and person. |
|
ExclusionCriteria |
Details |
Hemodynamically unstable, hearing impairment and on ventilator support |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Anxiety as per state trait anxiety inventory
Pain as per numerical rating scale |
Anxiety half an hour before dressing change.
Pain half an hour before, during and half an hour after dressing change |
|
Secondary Outcome
|
Outcome |
TimePoints |
Opioid and non opioid analgesics used during dressing change as per nursing charts |
Any time from Half an hour before to half an hour after dressing change. |
|
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
|
N/A |
Date of First Enrollment (India)
|
16/07/2015 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
published in journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to assess the effect of patient selected instrumental music on the level of state and trait anxiety, pain perception and opioid demand during dressing change among admitted burn patients. Alternate hypothesis: music therapy reduces pain anxiety and opioid demand among burn patients during dressing change at 0.05 level of significance. |