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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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