| CTRI Number |
CTRI/2025/11/097420 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study, we are looking at whether using a smartphone can help children feel less anxious or scared before they have surgery. |
|
Scientific Title of Study
|
EFFECT OF DISTRACTION WITH SMARTPHONE TO REDUCE PRE-OPERATIVE ANXIETY IN PAEDIATRIC PATIENTS-A RANDOMISED CONTROL 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 TANNU PRIYA |
| Designation |
M.D ANESTHESIOLOGY RESIDENT |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL |
| Address |
F3 DEPARTMENT OF ANESTHESIA, CIVIL HOSPITAL, B.J. MEDICAL COLLEGE, AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
8968373140 |
| Fax |
|
| Email |
tanupriya123.tp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANESTHESIOLOGY |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL |
| Address |
F3 DEPARTMENT OF ANESTHESIA, CIVIL HOSPITAL, B.J. MEDICAL COLLEGE, AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANESTHESIOLOGY |
| Affiliation |
B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL |
| Address |
F3 DEPARTMENT OF ANESTHESIA, CIVIL HOSPITAL, B.J. MEDICAL COLLEGE, AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY, CIVIL HOSPITAL, AHMEDABAD AND DR TANNU PRIYA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SUPPLY AND DR TANNU PRIYA |
| Address |
F3 DEPARTMENT OF ANESTHESIOLOGY, CIVIL HOSPITAL, B.J. MEDICAL COLLEGE, ASARWA, AHMEDABAD 380016 |
| Type of Sponsor |
Other [SMARTPHONE GIVEN BY PARENTS. DRUGS FROM GOVERNMENT SUPPLY. ] |
|
|
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 TANNU PRIYA |
B.J. MEDICAL COLLEGE, CIVIL HOSPITAL |
F3 DEPARTMENT OF ANESTHESIOLOGY, CIVIL HOSPITAL, B.J. MEDICAL COLLEGE, ASARWA, AHMEDABAD
Ahmadabad
GUJARAT |
8968373140
tanupriya123.tp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMITTEE, B.J. MEDICAL COLLEGE, CIVIL HOSPITAL, AHMEDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
JR CIRCUIT |
JR CIRCUIT WILL BE PROVIDED TO CHILDREN IN PRE OPERATIVE AREA AND mY-PAS SCORE WILL BE MEASURED. THEN AGAIN SCORE WILL BE MEASURED AT THE TIME OF SHIFTING, AND AT THE TIME OF INDUCTION. HEMODYNAMIC PARAMETERS WILL BE RECORDED THROUGHOUT THE OPERATION. THEN AFTER SHIFTING WATCHA SCORE WILL BE MEASURED |
| Intervention |
SMARTPHONE OF THE PARENTS |
INITIALLY my-PAS SCORE WILL BE MEASURED IN PRE OPERATIVE AREA. THEN SMARTPHONE OF THE PARENTS WILL BE PROVIDED TO CHILDREN IN PRE OPERATIVE AREA AND mY-PAS SCORE WILL BE MEASURED. THEN AGAIN SCORE WILL BE MEASURED AT THE TIME OF SHIFTING, AND AT THE TIME OF INDUCTION. HEMODYNAMIC PARAMETERS WILL BE RECORDED THROUGHOUT THE OPERATION. THEN AFTER SHIFTING WATCHA SCORE WILL BE MEASURED |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 2-12 years.
2. Pediatric patient undergoing elective surgeries
3. Either gender
4. ASA grade I, II, III
5. Consent from legally authorized representative |
|
| ExclusionCriteria |
| Details |
1. ASA status IV, V
2. Emergency surgeries
3. Children with developmental delay, cognitive defects or mood disorders
4. Parents not having smartphones
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare preoperative anxiety using the Modified Yale Preoperative Anxiety Score (mYPAS)
• Heart rate. |
To compare preoperative anxiety using the Modified Yale Preoperative Anxiety Score (mYPAS)
• Heart rate. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Intraoperative hemodynamics
• Emergence delirium in post op room after 10 minutes using Watcha Score
• Parental satisfaction. |
FROM INDUCTION TILL THE END OF SURGERY |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/11/2025 |
| 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="0"
Months="10"
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 STUDY IS TO SEE REDUCTION IN PRE OPERATIVE ANXIETY BY USING SMARTPHONE AS A DISTRACTION. IT WILL BE A RANDOMISED STUDY WITH RANDOMISATION DONE VIA ODD- EVEN TECHNIQUE. THE HYPOTHESIS IN OUR STUDY IS THAT DISTRACTION WITH SMARTPHONES HELPS IN REDUCING PRE OPERATIVE ANXIETY OF CHILDREN HENCE LOWER mY-PAS SCORE AND STABLE HEMODYNAMICS INTRAOPERATIVELY. |