| CTRI Number |
CTRI/2025/06/088217 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of art therapy on hospitalized children |
Scientific Title of Study
Modification(s)
|
Impact of art therapy on fatigue, sleep and anxiety among hospitalized children at AIIMS, New Delhi- A quasi experimental 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 |
Bharathi Priyadharshini S U |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
porta cabin 2, pediatric nursing, College of Nursing,
All India Institute of Medical Sciences New Delhi
South
DELHI
110049
India |
| Phone |
7838318289 |
| Fax |
|
| Email |
bpdharshini3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Cecilia. M. S |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Pediatric Nursing, College of Nursing,
All India Institute of Medical Sciences New Delhi
South
DELHI
110049
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharathi Priyadharshini S U |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Porta cabin-2, Pediatric Nursing, College of Nursing,
All India Institute of Medical Sciences New Delhi
South
DELHI
110049
India |
| Phone |
7838318289 |
| Fax |
|
| Email |
bpdharshini3@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110049. |
|
|
Primary Sponsor
|
| Name |
Bharathi Priyadharshini S U |
| Address |
College of Nursing
All India Institute of Medical Sciences,New Delhi- 110049. India
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 |
| Bharathi Priyadharshini S U |
All India Institute of Medical Sciences |
5A, 5B, 5C, 4C, Motheer and Child Block, All India Institute of Medical Sciences, New Delhi
110029
South
DELHI |
7838318289
bpdharshini3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z518||Encounter for other specified aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
art therapy |
5 days |
| Comparator Agent |
no intervention |
5 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
The children who are
- aged 6-18 years
-Able to understand and participate in the art therapy.
-Children hospitalized at least for 6 days
-Children whose caregiver have provided informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
The children who are
-With severe cognitive or developmental impairments
-In advanced life support
-Critically ill
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the impact of art therapy on fatigue among hospitalized children at AIIMS, New Delhi. |
5 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.To measure the impact of art therapy on sleep among hospitalized children.
2.To evaluate the impact of art therapy on anxiety among hospitalized children.
3.To find out the association between selected demographic variables & fatigue, sleep, anxiety among hospitalized children
4. To assess the level of satisfaction regarding art therapy among caregivers of the hospitalized children
|
5days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
19/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The title of my study is " Impact of art therapy on fatigue, sleep and anxiety among hospitalized children at AIIMS, New Delhi. Hospitalization can have profound effects on children, often leading to heightened anxiety, fatigue, and sleep disturbances due to medical procedures, separation from family, and an unfamiliar environment. Art therapy, including activities like drawing, painting, and origami, helps children cope with the challenges of hospitalization. This study aims to assess the effectiveness of art therapy on fatigue, sleep and anxiety among hospitalized children aged 6 - 18 years at AIIMS, New Delhi. Study design is a quasi experimental study. Pediatric wards 5A, 5B, 5C and 4C in Mother and Child Block will be taken as study setting. Children aged 6 - 18 years admitted in those wards will be selected as study participants. Data collection will be done using standardized tools - pediatric Functional Assessment of Chronic illness Treatment- Fatigue, Children’s Sleep habits Questionnaire, Stat and Trait Anxiety Inventory, Structured Caregiver Satisfactory Questionnaire. Data collection will be done for 3 months. Data analysis will be done using appropriate descriptive and inferential statistics. |