| CTRI Number |
CTRI/2024/03/064322 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the Effectiveness of Preparatory Informational Videos in Alleviating Preoperative Anxiety among Parents of Pediatric Surgery Patients |
|
Scientific Title of Study
|
Evaluating Peer Supportive Interventions to Reduce Preoperative Stress and Anxiety in Parents of Children Undergoing Surgery: A Randomized Controlled 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 |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishesh Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4007 Pediatric Surgery AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
|
Source of Monetary or Material Support
|
| infrastructutre, material- AIIMS; New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Vishesh Jain |
| Address |
4007 Pediatric Surgery AIIMS New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Vishesh Jain |
All India Institute of Medical Science (AIIMS) |
Room no. 762, 4007 Pediatric Surgery OPD, Mother and Child Block
New Delhi
DELHI |
8860080432
dr.vishesh79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parents of children undergoing daycare surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2D Animation video |
2D Animation video giving patient information regarding the daycare surgical procedure and its management. |
| Comparator Agent |
Conventional method |
Doctor giving patient information regarding the daycare surgical procedure and its management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents of new pediatric patients up to 14 years of age undergoing day care surgeries.
2. No history of undergoing any day care surgeries by the participant or within the family.
3. Participants who have not received any previous literature or information on day care surgeries.
4. Parents willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Parents unwilling to participate.
2. Parents who can’t understand Hindi or English
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Baseline data of knowledge.
2. Post-intervention data on knowledge.
3. Difference in pre-intervention and
post-intervention scores.
4. Retention of Knowledge |
1.Baseline
2. 2 weeks
3. 6 weeks
4. 7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhanced understanding and retention of information among parents regarding the daycare surgical procedure and its management. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="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 - NO
|
|
Brief Summary
|
The study aims to compare the effects of animated video methods with traditional verbal instruction on the comprehension and integration of information by parents. It seeks to establish the effectiveness of preparatory informational videos in enhancing parental understanding and engagement in the context of pediatric day-care surgeries. This comparison will contribute to developing more effective methods for educating parents, ensuring they are adequately prepared for their child’s surgery and associated care processes.
Research Question Does the use of 2D animated informational videos reduce preoperative anxiety before day care surgeries in parents more effectively than traditional verbal instructions? Null hypothesis There is no significant difference in the reduction of preoperative anxiety levels between parents who receive traditional verbal instructions and those who watch 2D animated informational videos.
|