| CTRI Number |
CTRI/2020/03/024150 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
22/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
THE EFFECT OF MUSIC THERAPY ON QUALITY OF RECOVERY IN PATIENTS UNDERGOING ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
TO DETERMINE THE EFFECT OF MUSIC THERAPY ON QUALITY OF RECOVERY IN PATIENTS UNDERGOING ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA- A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patil Dipti Devidas |
| Designation |
Resident , Anaesthesiology |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology Armed Force Medical College
Solapur Road Wanowrie , Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7057656166 |
| Fax |
|
| Email |
dr.dipti4960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brijindera Sethi |
| Designation |
Associate Professor , Colonel |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology Armed Force Medical College
Solapur Road Wanowrie , Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7030866338 |
| Fax |
|
| Email |
drbssethi72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patil Dipti Devidas |
| Designation |
Resident , Anaesthesiology |
| Affiliation |
Armed Force Medical College |
| Address |
Department of Anaesthesiology Armed Force Medical College
Solapur Road Wanowrie , Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7057656166 |
| Fax |
|
| Email |
dr.dipti4960@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Wanowrie, Pune, Maharashtra 411040 |
|
|
Primary Sponsor
|
| Name |
Dr Patil Dipti Devidas |
| Address |
Department of Anaesthesiology, Armed Force Medical College,
Solapur Road,Wanowrie
Pune
MAHARASHTRA
411040
India
|
| 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 Patil Dipti Devidas |
Command Hospital (Southern Command) |
Department of Anaesthesiology,
Solapur
Road,Wanowrie,
411040
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7057656166
dr.dipti4960@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,Armed Force Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of earphones with music( music will be played of patients choice ,if no choice then anaesthesiologist choice will be played) |
Earphones will be attached to the patients and music will be played after induction until the end of surgery. |
| Comparator Agent |
Application of earphones without music |
Earphones will be attached to the patients and music will not be played after induction until the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients undergoing abdominal surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
-ASA 3 or more
-Emergency surgeries
-Cognitive or psychiatric disorders
-Hearing – impairing disease
-Chronic treatment with analgesics
-Patients not extubated immediately after surgery
-Patients who deny consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the difference in quality of recovery ( Riker Sedation - Agitation Scale ) in patients undergoing abdominal surgeries under general anaesthesia with and without music therapy. |
5 mins, after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare VAS( Visual Analogue Scale )score after awakening following surgery between two groups. |
15 mins, after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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 2 |
|
Date of First Enrollment (India)
|
15/04/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a double blinded randomised control trial to find the difference in quality of recovery in patients undergoing abdominal surgeries under general anaesthesia with and without music therapy. |