| CTRI Number |
CTRI/2024/03/064251 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Easing Kids Worries Before Surgery: How Videos Help Reduce Anxiety for Both Children and Parents - A Pilot Study" |
|
Scientific Title of Study
|
Evaluating the Impact of Pediatric Preanesthesia Preparation Animated Video Intervention on Alleviating Preoperative Anxiety in Children and Parents. A Randomized Controlled Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. Sampurnanand Medical College Jodhpur |
| Address |
Department of anaesthesiology Dr. Sampurnanand Medical College Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. Sampurnanand Medical College Jodhpur |
| Address |
Department of anaesthesiology Dr. Sampurnanand Medical College Jodhpur
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. Sampurnanand Medical College Jodhpur |
| Address |
Department of anaesthesiology Dr. Sampurnanand Medical College Jodhpur
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Dr. S. N. Medical College, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr. Sampurnanand Medical College Jodhpur |
| Address |
Dr. S N Medical College Jodhpur Rajasthan |
| 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 Naveen Paliwal |
Umaid Hospital |
Operation theatre complex first floor, Department of anaesthesiology, pediatric surgery operation theatre.
Jodhpur
RAJASTHAN |
09950230213
drnaveenpaliwal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr.Sampurnanand Medical College |
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 |
| Intervention |
Pediatric Preanesthesia Preparation Animated Video |
The children will be shown the Preanesthesia Preparation Animated video in the mobile phone/tablet/laptop in EI group . Any queries of child or parent related to video/ intervention and anesthesia will be answered by the observers. |
| Comparator Agent |
Standard institution protocol will be followed |
Children in the control group will receive standard care, which includes only informative interventions including peri-operative procedure, postoperative care as per institution protocol by nurses or resident doctor to parents or children. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All patients age between 5-10 years of age, either gender undergoing elective surgery lasting less than 120 minutes |
|
| ExclusionCriteria |
| Details |
Parents refusal, emergency surgery/ not consenting/ ASA III or IV, syndromic children, general anesthesia exposures ≥2, children with significant cognitive impairment or developmental delays impairing language or vision, and children on psychotropic medications, chronic illness, day care surgery, children who don’t understand Hindi language. Children who will not watch the whole video and interrupt it in between will be considered as dropouts. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Child anxiety score |
The day before surgery and during transport of children from preanaesthesia room to OR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parent anxiety score, Child fear score and Child behaviour score |
The day before surgery before study intervention and during transport of the children from preanaesthesia score to OR
Child behaviour score at 7th and 30th day post-discharge |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
This pilot study addresses the development and assessment of a unique video, "Pediatric Preanesthesia Preparation†(CF-5526/2023), combining animation with educational content in Hindi, the national language. This four-minute video aims to alleviate preoperative anxiety by providing a virtual experience of the perioperative anesthesia procedure. The video can be freely shared and accessed on smartphones, tablets, or laptops. We hypothesize that the "Pediatric Preanesthesia Preparation" video will significantly reduce preoperative anxiety in children and their parents. By offering a realistic depiction of the anesthetic procedure, the video aims to address key concerns, including fear of cannulations, the unfamiliar OT environment, pain, and postoperative recovery, all presented in a familiar language. |