| CTRI Number |
CTRI/2024/11/076368 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diversional therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of coloring pictures in reducing anxiety among hospitalized children |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of coloring picture book in reducing hospitalization anxiety of hospitalized children 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 |
T Thuileiphy |
| Designation |
Tutor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department-College of Nursing
Room no 106
First floor
AIIMS, Basni phase 2 Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9990296932 |
| Fax |
|
| Email |
thuileiphyt@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Chandra Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department-College of Nursing
Room no 103
First floor
AIIMS, Basni phase 2 Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Chandra Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department-College of Nursing
Room no 103
First floor
AIIMS, Basni phase 2 Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS Jodhpur, Rajasthan pin 342005, India. |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Room no 106
College of Nursing
AIIMS Jodhpur 342005 Rajasthan India
Rajasthan India |
| 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 Mukesh Chandra Sharma |
AIIMS Jodhpur |
Department of Pediatric wards 2D, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9779534307
sharmamukeshchandra0704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coloring picture books |
Different types of colouring books will be utilized and this will be provided to child based on his or her interest of colouring material. Participants in each group will be given instructions for completing their assigned colouring activity intervention, and each participant received a box of colour pencils of varying shades. The colouring sessions will be conducted in pediatric ward by researcher. The participants will be instructed to remain quiet and avoid distractions from mobile, etc. during the activity. Participants will complete a brief demographic questionnaire. The intervention groups will be given 20 minutes to complete their assigned colouring activity, and upon completion, children will be responded to the anxiety assessment tool following the intervention activities. |
| Comparator Agent |
Routine care |
Waitlist control strategy will be used in the control group. Waitlist control groups are often used when it would be unethical to deny participants access to treatment. In this with delayed treatment, the control group eventually receives the full experimental treatment, but treatment is deferred. Control group children will be engaged in coloring picture books, after doing observation OC1 and OC2. This control group serves as an untreated comparison group during the study, but eventually goes on to receive treatment later.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Hospitalized children of age group 6-12 years.
Children who can color picture books |
|
| ExclusionCriteria |
| Details |
Hospitalized children other than age group of 6-12 years
Children whose parents do not allow them to participate in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the effects of stress on admitted children through Coloring picture books as a diversion therapy |
3 month |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The hospital is a new environment for children where they need to adapt during their treatment process. The impact of hospitalization on preschool children has both short-term and long-term impacts which may impair the child’s development and healing process. The challenges faced by most of the sick during hospitalization include adjusting to the environment and people who care for them, including dealing with separation problems, and nursing procedures and medicines they receive. These conditions make children afraid and anxious and it affects the length of hospital stay, exacerbate the child’s condition, and can even cause death in the child. Therefore, it is important to minimize the impact of hospitalization. One of the interventions to reduce anxiety in hospitalized children is Play Therapy. Many studies have shown that coloring is effective in reducing anxiety due to hospitalization of preschool children. The purpose of this study is to evaluate the effectiveness of coloring picture books in reducing hospitalization anxiety of children admitted to pediatric ward.
H1- There will be a significant decrease in the hospitalization anxiety score of the experimental group as compared to the control group.
|