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CTRI Number  CTRI/2024/02/063273 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of music therapy in lower limb surgeries.  
Scientific Title of Study   To study the effect of music therapy in patients undergoing lower limb orthopedic surgeries under subarachnoid block.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa Ahirwar 
Designation  Junior resident 
Affiliation  Gandhi medical college 
Address  Department of anaesthesia ,Gandhi medical college ,Bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  7898649691  
Fax    
Email  richa.a1507@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yashwant Dhawale 
Designation  Professor 
Affiliation  Gandhi medical college 
Address  Department of anaesthesia ,Gandhi medical college ,Bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  9425667373  
Fax    
Email  yashwantdhawalegmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana Pandey 
Designation  Assistant professor 
Affiliation  Gandhi medical college 
Address  Department of anaesthesia ,Gandhi medical college ,Bhopal

Bhopal
MADHYA PRADESH
462001
India 
Phone  7898169898  
Fax    
Email  pandeyvandana92@gmail.com  
 
Source of Monetary or Material Support  
Gandhi medical college ,bhopal 
 
Primary Sponsor  
Name  Gandhi medical college 
Address  Department of anaesthesia, Gandhi medical college, Bhopal  
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 
Dr Richa Ahirwar  Gandhi medical college  Department of anaesthesia ,Gandhi medical college ,Bhopal
Bhopal
MADHYA PRADESH 
7898649691

richa.a1507@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of ASA grade - I , ASA grade II
2.Age group 18-60 years of either sex.
3.All patients scheduled for lower limb orthopedics surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  1.Patient refusal or not giving consent.
2.Pregnancy
3.Patients with co-morbidities
4.Patients with hearing impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The effect of music therapy on patients intraoperative anxiolytic drug requirements undergoing lower limb orthopedic surgeries.  At 0,5,10,15,20,25,30,40,50,60minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of music therapy on patients vital parameters and patients satisfaction score.  At 0,5,10,15,20,25,30,40,50,60minutes
 
 
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   N/A 
Date of First Enrollment (India)   02/03/2024 
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="2"
Days="1" 
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  

There is an associated stress and anxiety in patients undergoing any form of major surgery, this can hamper the health and recovery of patients. Adding to this the environment of the operation theatre with its noise of monitors, surgical instrumentation and doctor’s conversations add on to the anxiety of the patient.

Therefore, sedative and anxiolytic drugs are regularly administered before and during surgery, for the purpose of calming patients, but at the cost of dose dependent central nervous system and cardio-respiratory system depression.

Different drugs have been tried in the past to achieve sedation, the most prominent among them being diazepam, midazolam , dexmedetomidine, and propofol. Non-pharmacological alternatives like acupressure, hypnosis, therapeutic suggestions and music therapy have also been tried in the past, with varying results, to avoid the complications due to the sedatives and anxiolytics drugs.

Amongst the various non-pharmacological methods, music has been tried in different medical settings with varied success rate.

Music, especially one around 70 beats per minute can cause brain to sync with beat generating alpha brain waves. These waves are what are present when we are relaxed and conscious. Hence we intend to determine the effect of music therapy on patients vital parameters and intraoperative requirements of sedatives/anxiolytic drugs.

 
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