| CTRI Number |
CTRI/2021/09/036315 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [music therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of music played during caeserean section on sedation, anxiety and haemodynamic responses among patients undergoing it under spinal anaesthesia |
|
Scientific Title of Study
|
The effect of intraoperative music on sedation, anxiety and haemodynamic responses among patients undergoing lower segment caesarean section under spinal anaesthesia -A randomized controlled interventional study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesia
Second Floor
Dhanvantri Complex
SMS Medical College and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesia
Second Floor
Dhanvantri Complex
SMS Medical College and attached hospitals
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruby Singhal |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesia
Second Floor
Dhanvantri Complex
SMS Medical College and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8000394351 |
| Fax |
|
| Email |
rubymbbs2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia
SMS Medical College and attached hospitals
|
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department Of Anaesthesia
Second Floor
Dhanvantri Complex
SMS Medical College and attached hospitals
Jaipur 302004
|
| 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 Ruby Singhal |
SMS Medical College and attached hospitals |
Department Of Anaesthesia
Second Floor
Dhanvantri Complex
SMS Medical College and attached hospitals
Jaipur 302004
Jaipur
RAJASTHAN |
8000394351
rubymbbs2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S M S Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Headphones |
Headphones not playing any music till end of surgery |
| Intervention |
Headphones |
Headphones playing instrumental music till end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Surgery – lower segment caesarean section under spinal anaesthesia
Age group – 18 to 35 years
Patient who give written informed consent in vernacular language
American Society of Anaesthesiologist (ASA) grade I and II patients
|
|
| ExclusionCriteria |
| Details |
Patients with hearing impairment
Patients with chronic pain
Patients with any known psychiatric and memory disorder
Professional musicianship
Patients with history of drug abuse or addictions
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in mean BIS index at different time intervals from baseline between the two groups. |
60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of anxiety scores by visual analogue scale for anxiety between the two groups |
Sixty minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/09/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To
study the effect of presence or absence of instrumental music on sedation, anxiety and haemodynamic parameters in
patients undergoing caesarean section under spinal anaesthesia. |