| CTRI Number |
CTRI/2025/06/088556 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mandala Art Therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mandala Art Therapy on attention level among Attention Deficit Hyperactivity Disorder children |
|
Scientific Title of Study
|
EFFECTIVENESS OF MANDALA ART THERAPY ON ATTENTION LEVEL AMONG ATTENTION DEFICIT HYPERACTIVITY DISORDER CHILDREN ATTENDING EARLY INTERVENTION CENTRE IN A TERTIARY CARE HOSPITAL IN WESTERN MAHARASHTRA. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Shilpa |
| Designation |
PG Trainee |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
MSc Nursing Child Health Nursing First Year Trainee Officer College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7459058853 |
| Fax |
|
| Email |
shilpasubramanian2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAYALAKSHMI A S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
Child Health Nursing College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9560604892 |
| Fax |
|
| Email |
jaya22118@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Shilpa |
| Designation |
PG Trainee |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
MSc Nursing Child Health Nursing First Year Trainee Officer College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7459058853 |
| Fax |
|
| Email |
shilpasubramanian2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S Shilpa |
| Address |
College of Nursing AFMC Pune |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 |
| S Shilpa |
COMMAND HOSPITAL |
EARLY INTERVENTION CENTRE, SOUTHERN COMMAND, GOLIBAR MAIDAN, WANWADI, PUNE
Pune
MAHARASHTRA |
7459058853
shilpasubramanian2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mandala art therapy on attention level among Attention Deficit Hyperactivity Disorder children |
22 children of control group will be given routine treatment, post test will be taken for both groups on the 8th week. |
| Intervention |
Mandala Art Therapy on attention level among Attention Deficit Hyperactivity Disorder children |
Pre test will be taken for both groups ,then Mandala Art Therapy will be given to 22 children with ADHD, 03 sessions per week for 30 minutes for 06 weeks duration |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6- 12 years diagnosed with Attention Deficit Hyperactivity Disorder.
2. Children with no visual or motor impairments that might interfere with participation in Mandala Art Therapy. |
|
| ExclusionCriteria |
| Details |
1. Children with severe intellectual disabilities, that might interfere with participation.
2. Children with acute psychiatric conditions like severe anxiety and depression requiring immediate medical attention.
3. Children with any physical disabilities affecting their ability to engage in art therapy activities. |
|
|
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 |
| Improvement in attention level |
pre intervention score of attention
post intervention score of attention after 01 week of completion of intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
26/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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)
|
This is a randomized controlled trial to assess the effectiveness of Mandala Art Therapy on attention level among attention deficit hyperactivity disorder children attending Early Intervention Centre in a tertiary care hospital in Western Maharashtra. 22 children with attention deficit hyperactivity disorder will be given Mandala Art Therapy for 06 weeks duration, 03 sessions per week for 30 minutes and 22 children will receive the routine treatment. |