FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070563 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Administration of music therapy in the pre operative and postoperative period]  
Study Design  Other 
Public Title of Study   Effect of music in anxiety and pain in patients undergoing cardiac surgery  
Scientific Title of Study   Effect of music therapy on pain and anxiety in adult patients undergoing cardiac surgery through midline sternotomy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwanth G 
Designation  PG Resident  
Affiliation  VMMC and Safdarjung hospital 
Address  Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi

New Delhi
DELHI
110029
India 
Phone  7402373791  
Fax    
Email  ashwanthash123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajpal Singh 
Designation  Professor and Consultant  
Affiliation  VMMC and Safdarjung hospital 
Address  Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi DELHI

New Delhi
DELHI
110029
India 
Phone  9911858311  
Fax    
Email  Doctorrajpal04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajpal Singh 
Designation  Professor and Consultant  
Affiliation  VMMC and Safdarjung hospital 
Address  Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi DELHI

New Delhi
DELHI
110029
India 
Phone  9911858311  
Fax    
Email  Doctorrajpal04@gmail.com  
 
Source of Monetary or Material Support  
Vardhaman Mahavir Medical College and Safdarjung Hospital, Ansari nagar east, New Delhi, India, 110029 
 
Primary Sponsor  
Name  Vardhaman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi DELHI 110029 India 
Type of Sponsor  Government medical college 
 
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 
DrAshwanth G  VMMC and Safdarjung Hospital   Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi New Delhi DELHI 110029 India
New Delhi
DELHI 		 7402373791

ashwanthash123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Protocol Review Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I254||Coronary artery aneurysm and dissection, (3) ICD-10 Condition: I708||Atherosclerosis of other arteries, (4) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music therapy   Administration of 20 minutes of music therapy for subjects in prepping and 2,12,24 hours of post extubation 
Comparator Agent  Music therapy j  By administering music therapy we are trying to see whether post operative pain and anxiety is reduced or not 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients fulfilling the criteria of American Society of Anaesthesiologists (ASA) Grade II
and III, aged between 18-65 years posted for elective cardiac surgery necessitating midline
sternotomy.
 
 
ExclusionCriteria 
Details  1. Inability to communicate effectively/ psychiatric illness
2. Patients who are expected to remain intubated for more than 24 hours post surgery 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of music therapy on postoperative pain score at 2hours, 1 2 hours and 24
hours post extubation in patients undergoing cardiac surgery through midline sternotomy 		 20 minutes of music therapy will be provided each time before assessing the pain score 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of music therapy on:
• Pre induction anxiety score (after music therapy)
• Post extubation anxiety scores (STAI - State Anxiety Score) at 2 hours,12
hours and 24 hours post extubation
• Number of rescue analgesia in the first 24 hours post extubation
• Quality of sleep in the first 24 hours post extubation 		 20 minutes of music therapy will be provided each time before assessing the patient  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/07/2024 
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  

In recent times music therapy is used as one among the various non-opioid based therapeutic which is often used as a non pharmacological supplement. Here we are going to study the effect of music therapy in reducing post operative pain and anxiety in patients undergoing cardiac surgery through midline sternotomy.The methodology will be after explaining about the study and getting informed consent the subjects will be divided into two groups (group - M music therapy group -C control ) using computer generated random tables then 20 minutes music therapy will be given to M group subjects in the pre op and 2,12,24 hours post extubation and no intervention will be done for  C group subjects. Pain and STAI anxiety score will be assessed after every session. We hypothesize that the music therapy will reduce pain and anxiety in patients undergoing cardiac surgery through midline sternotomy.we are also assessing quality of sleep in the postoperative period.

 
Close