| CTRI Number |
CTRI/2025/02/081253 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Leisure satisfaction and percieved stress] |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to find out weather structured pattern art in reducing stress and enhance happiness from activities in people with mental illness |
|
Scientific Title of Study
|
A study to assess effectiveness of Zentangle art therapy on perceived stress and leisure
satisfaction among residents with Schizophrenia and Schizoaffective disorder from
selected psychosocial rehabilitation centres of Udupi district. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anna Susan C |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Room.no: 402
2nd year MSc Nursing
Manipal College of Nursing
Manipal Academy Of Higher Education
Madahav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8848679890 |
| Fax |
|
| Email |
annachirakkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Flavia Sharlet Noronha |
| Designation |
Assitant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No: 601
Department of Psychiatry (Mental Health Nursing) Manipal College of Nursing
Manipal Academy Of Higher Education
Madahav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483927967 |
| Fax |
|
| Email |
flavia.noronha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Flavia Sharlet Noronha |
| Designation |
Assitant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No: 601
Department of Psychiatry (Mental Health Nursing) Manipal College of Nursing
Manipal Academy Of Higher Education
Madahav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483927967 |
| Fax |
|
| Email |
flavia.noronha@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anna Susan C |
| Address |
Manipal college of nursing
MAHE manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anna Susan C |
Baliga Hospital |
Room: Activity room Ground floor
Abhaya Psychiatric rehabilitation center
Annappanagar, Salikeri, Bramavara, 576213
Udupi
KARNATAKA |
8848679890
annachirakkal@gmail.com |
| Anna Susan C |
Kasturba Hospital |
Room: Therapy room Ground floor
Hombelaku psychiatric rehabilitation center
Madhav nagar, saralabettu, MAHE, Manipal
Udupi
KARNATAKA |
8848679890
annachirakkal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Zentangle art therapy |
For control group pretest will be conducted and after 2 weeks post test will be conducted. After 2 weeks from post test a follow up test will be conducted followed by a small section of zentangle art therapy training by the researcher will be provided |
| Intervention |
Zentangle art therapy |
Samples will be selected using purposive sampling and will be divided into experimental and control group. Pretest will be conducted using LSQ, LSS-SF and PSS scale to measure perceived stress and leisure satisfaction. 2 week intervention will be provided on alternative days. Researcher teach zentangle art to participants for one hour. Post test will be conducted after 2 week using same tools.For the next 2 weeks participants practice zentangle art for one hour under the supervision of researcher and follow up test will be conducted using same tool. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with schizophrenia or schizoaffective disorder, whose
CGI-S score is less than 4 as determined by a physician.
Individuals getting stable dose of main medicine for last 6 weeks.
Individual who are willing to participate
Individual above 18 years and below 60 years |
|
| ExclusionCriteria |
| Details |
Patients who are showing exacerbation of symptoms at the time of data
collection.
Residents with comorbid uncontrolled medical conditions and psychiatric
conditions such as substance abuse, OCD etc…. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be change in perceived stress and leisure satisfaction scores from baseline to post intervention and follow-up measured using validated assessment scales to evaluate the effectiveness if zentangle art therapy among residents with schizophrenia and schizoaffective disorder |
The study will begin with a pre-test, followed by two weeks of intervention. After the intervention period, a post-test will be conducted. Participants will then engage in independent practicing of Zentangle art under supervision for the next two weeks. Finally, a follow-up test will be conducted, making the total duration of the study four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/03/2025 |
| 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="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
|
The study will be done only after approval of CTRI. Pretest will be conducted followed by intervention in which zentangle art will be taught and after 2 week post test will be conducted. Next 2 week participants will practice zentangle art under supervision and follow up test will be conducted. The participants will be recruited only after consent. |