| CTRI Number |
CTRI/2024/12/077739 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| 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
|
The researcher wanted to see if doing Mandala Art Therapy could reduce feelings of Depression- Anxiety- Stress and improve Psychosocial functioning among the patients admitted in psychiatric ward at JIPMER hospital. |
|
Scientific Title of Study
|
Effect of Mandala Art Therapy on Depression Anxiety Stress and Psychosocial functioning among psychiatric inpatients at JIPMER hospital 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 |
Puna Sunku |
| Designation |
M.Sc. Psychiatric Nursing student |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research. |
| Address |
M.Sc. Psychiatric Nursing, College of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8798049382 |
| Fax |
|
| Email |
punasunku54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janarthanan B |
| Designation |
Nursing Tutor |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research. |
| Address |
Department of Psychiatric Nursing. College of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788964015 |
| Fax |
|
| Email |
jenu.bcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janarthanan B |
| Designation |
Nursing Tutor |
| Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research. |
| Address |
Department of Psychiatric Nursing. College of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788964015 |
| Fax |
|
| Email |
jenu.bcc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research.
Puducherry 605006, India. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research. |
| Address |
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research.
Puducherry - 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Janarthanan B |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Psychiatric department. Ward number 82.
Pondicherry
PONDICHERRY |
9788964015
jenu.bcc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee- Interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (2) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mandala Art Therapy |
30-40 minutes maximum for 3 times a week for 3 weeks. |
| Comparator Agent |
Routine Psychiatric care |
Routine Psychiatric care everyday according to the patients conditions for 3 weeks maximum. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 18-60years
2. Patients who could speak Tamil and/or English |
|
| ExclusionCriteria |
| Details |
1. Patients who exhibit severe psychiatric symptoms (e.g., injuring themselves or others) and those patients who appear suicidal and violent within past 48 hours.
2. Patients with physical disabilities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Mandala Art Therapy on the level of Depression, Anxiety, Stress and Psychosocial Functioning between the intervention and control group. |
30 to 40 minutes, 3 times a week for 3 weeks maximum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the socio-demographic and clinical variables of both the groups, associated with their level of Depression, Anxiety, Stress and Psychosocial Functioning. |
30 to 40 minutes, 3 times a week for 3 weeks maximum. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
17/12/2024 |
| 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="0"
Days="6" |
|
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 a Randomized Controlled Trial to assess the effectiveness of Mandala Art Therapy on the level of Depression-Anxiety-Stress and Psychosocial Functioning among Psychiatric inpatients. Patients who meet the inclusion criteria will be enrolled from the psychiatric ward. Informed consent will be obtained from the participants after hat the pre-test questionnaire will be administered which includes demographic data, DASS-21 scale (Depression-Anxiety-Stress scale) GAF scale (Global Assessment of Functioning). The participants will be provided pre-drawn mandala pattern and color pencils for coloring, duration of the coloring will be 30 to 40 minutes maximum, 3 times a week for 3 weeks maximum. Post test assessment will be done twice that is during the time of discharge and after 2 months of discharge at the psychiatric out-patients department. |