| CTRI Number |
CTRI/2024/03/064645 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [perioperative use of smartphone to reduce anxiety ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to check the use of smartphone in children to reduce anxiety before surgery. |
|
Scientific Title of Study
|
Use of smartphoneto reduce preoperative anxiety in children before anaesthesia. |
| 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. Anjali Unadkat |
| Designation |
Assistant Professor |
| Affiliation |
GMERS medical college,junagadh |
| Address |
"karunanidhan",bhagwatipark,near podar kids school,zanzarda road,chobari road,junagadh
310, Department of Anaesthesiology, G.M.E.R.S. Medical College, Majewadi gate, Junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
8866628529 |
| Fax |
|
| Email |
anjali.unadkat2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anjali Unadkat |
| Designation |
Assistant Professor |
| Affiliation |
GMERS medical college,junagadh |
| Address |
"karunanidhan",bhagwatipark,near podar kids school,zanzarda road,chobari road,junagadh
310, Department of Anaesthesiology, G.M.E.R.S. Medical College, Majewadi gate, Junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
8866628529 |
| Fax |
|
| Email |
anjali.unadkat2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anjali Unadkat |
| Designation |
Assistant Professor |
| Affiliation |
GMERS medical college,junagadh |
| Address |
"karunanidhan",bhagwatipark,near podar kids school,zanzarda road,chobari road,junagadh
310, Department of Anaesthesiology,G.M.E.R.S. Medical College, Majewadi gate Junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
8866628529 |
| Fax |
|
| Email |
anjali.unadkat2@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS medical college,junagadh |
|
|
Primary Sponsor
|
| Name |
Anjali Unadkat |
| Address |
"karunanidhan",bhagwatipark,near podar kids school,zanzarda,chobari road,junagadh |
| 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 Anjali Unadkat |
Block No. 307-8, General surgery and orthopaedic Operation Theatre , GMERS Junagadh. |
307,Third floor,GMERS medical college and hospital,Majevadi Gate junagadh,gujarat
Junagadh
GUJARAT |
8866628529
anjali.unadkat2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, GMERS Medical College,Junagadh. |
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 |
Conventional protocols |
following Conventional protocols without use of mobilephone in perioperative period |
| Intervention |
Use of smartphone in perioperative period. |
Use of video games and animated cartoons for 15 minutes, 20 minutes before procedure. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.All children aged between 3 to 12 years
2. Children undergoing elective surgery
3. ASA status 1 or 2 |
|
| ExclusionCriteria |
| Details |
1.Emergency surgery
2. Mentally retarded children
3. hearing impairment
4. Children below 3 year and above 12 year of surgery
5. Uncooperative parents
6. On any psychiatric medication |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| perioperative anxiety assesed by mypas.23 score |
perioperative anxiety assesed by mypas.23 score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemodynamic parameters (pulse , blood pressure,spo2) |
1. preintervention
2. 20 minutes after smartphone
3. after entering operation theatre
4. every 15 minutes after starting of procedure
|
|
|
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)
|
05/04/2024 |
| 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="0"
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
|
this study is about wheather the use of smartphones before operative procedure reduces the anxiety in children or not!!we are providing smartphones to children before operative procedure and showing them their favourite animated videos and games and then we are observing mYPAS.23 scale to study whether this intervention is helpful in reducing their anxiety before operative procedures or not |