| CTRI Number |
CTRI/2025/07/091838 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Toy Car Ride, Video Distraction and Oral Premedication for reducing Preoperative anxiety in Children Aged 2-7 Years Undergoing Elective Surgery |
|
Scientific Title of Study
|
Comparison of Toy Car, Video Display and Premedication in Reducing Preoperative Anxiety in Children Undergoing Elective Surgery- An Open Labelled Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhikshitha P |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care Medicine |
| Address |
Department of Anaesthesiology and Critical Care Medicine, All India Institute Of Medical Sciences (AIIMS)
Marudha Industrial Area Phase-2, Basni,
Jodhpur
Rajasthan
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9994685111 |
| Fax |
|
| Email |
psdhikshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa Goyal |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care Medicine, AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences (AIIMS), Marudhar Industrial area phase II, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996880 |
| Fax |
|
| Email |
drshilpagoyal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Goyal |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care Medicine, AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical sciences (AIIMS), Marudhar Industrial area phase II, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996880 |
| Fax |
|
| Email |
drshilpagoyal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Medical Sciences (AIIMS), Basni Industrial Area Phase- II, Jodhpur, Rajasthan, India 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Jodhpur |
| Address |
Basin Industrial area phase II JODHPUR RAJASTHAN 342005 |
| 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 |
| Dr Dhikshitha P |
All India Institute of Medical Sciences (AIIMS) |
Department of Anaesthesiology and Critical
Care, 3rd floor, DnT block, All India
Institute of Medical Sciences (AIIMS),
Phase II, Basni Industrial Area, Jodhpur.
Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9994685111
psdhikshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous midazolam and ketamine |
Premedication in the form of IV Midazolam 0.5 mg/kg and IV Ketamine 0.5 mg/kg will be given to the child 20 minutes before induction and child will be taken on the trolley to the OT.
|
| Intervention |
Toy car
Audio visuals |
The child will be allowed to ride in the toy car in the preoperative area for 20 min before induction and then will be taken in the OT on the toy car itself.
A video of the child’s interest will be played for 20 minutes before induction in the preoperative area and child will be taken in the OT on the trolley while continuing watching the video.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients belonging to the group of ASA I/II and in the age group of 2-7 years scheduled to undergo elective surgeries. |
|
| ExclusionCriteria |
| Details |
1. ASA III/ IV
2. Children undergoing emergency surgery
3. Neuropsychiatry disease with delayed psychomotor development
4. Significant hearing/ Visual
Impairment
5. Onset or H/O sleep apnea or adenoid hypertrophy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in anxiety scoring mYPAS-SF score when shifting to OR with Parental separation versus baseline |
Baseline, Parental separation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the difference in mYPAS-SF score when shifting to OR Table versus baseline (A2-A0), difference in mYPAS-SF when shifting to OR table versus at the time of parental separation ( A2-A1) |
Baseline, Parental separation, While shifting to OR table |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 4 |
|
Date of First Enrollment (India)
|
06/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [psdhikshi@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
. |