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
|
|
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
|
|
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
|
|
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. |