| CTRI Number |
CTRI/2020/03/023884 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
06/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between 2 ways of calming the children before surgery with either showing them a video or telling them about the procedure |
|
Scientific Title of Study
|
A non-inferiority,randomized controlled trial on Information Based v/s Distraction Technique for preoperative anxiety reduction in children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanitha N |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care,
PGIMER
SECTOR-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9916872121 |
| Fax |
|
| Email |
vinihoney01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Jain |
| Designation |
Additional professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care,
PGIMER
SECTOR-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900171 |
| Fax |
|
| Email |
Jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanitha N |
| Designation |
Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care,
PGIMER
SECTOR-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9916872121 |
| Fax |
|
| Email |
vinihoney01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
PGIMER |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care
4th Floor
Nehru Block
PGIMER
Sector 12 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vanitha N |
Postgraduate institute of medical education and research and research |
Department of anaesthesia and intensive care, 4th floor
Nehru hospital building, PGIMER,SECTOR 12
Chandigarh
CHANDIGARH |
9916872121
vinihoney01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Distraction Group |
Children will be made to see a video of their choice before induction to anaesthesia |
| Intervention |
Information Group |
Children will be shown video explaining the procedure before induction to anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 undergoing ambulatory surgery |
|
| ExclusionCriteria |
| Details |
Mentally challenged
Deaf child
Cerebral palsy
Premedicated child |
|
|
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 |
| mYPAS Score |
Baseline
10 minutes after intervention
During induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Induction compliance checklist |
During induction |
| Analgesic requirement |
Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes. |
| Emergence Agitation |
Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes. |
| Parental anxiety |
30 minutes before surgery |
| pain scores |
Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes. |
| Parental satisfaction |
After surgery |
| Negative outcome |
15 days (telephonically) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/03/2020 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a trial going to compare information based v/s distraction technique for anxiety reduction among 6-12ys children undergoing ambulatory surgery.80 children will be recruited. The purpose of the trial is to prove information based technique for induction is non-inferior to distraction techniques . Preoperative anxiety will be assessed by using mYPAS scoring is the primary objective of our study. Since we dint start recruiting it’s difficult to comment on our findings. |