| CTRI Number |
CTRI/2025/07/090372 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Art therapy for alcoholics in reducing anxiety. |
|
Scientific Title of Study
|
Effect of Mandala coloring on anxiety among individuals diagnosed with alcohol dependence syndrome admitted in a tertiary care hospital, Mangalore. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthi Sreekumar K M |
| Designation |
Post Graduate Student |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING MANGALORE |
| Address |
Department Of Mental Health Nursing Fourth Floor Father Muller College Of Nursing Father Muller Road Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
08921553018 |
| Fax |
|
| Email |
keerthimlover@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MsSanthipriya Montereo |
| Designation |
Professor |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING MANGALORE |
| Address |
Department Of Mental Health Nursing Fourth Floor FATHER MULLER COLLEGE OG NURSING FATHER MULLER ROAD KANKANADY MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
87224293 |
| Fax |
|
| Email |
shntpriya3@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Santhipriya Montereo |
| Designation |
Professor |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING MANGALORE |
| Address |
Department Of Mental Health Nursing Fourth Floor FATHER MULLER COLLEGE OG NURSING FATHER MULLER ROAD KANKANADY MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
87224293 |
| Fax |
|
| Email |
shntpriya3@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Keerthi Sreekumar K M |
| Address |
Father Muller College Of Nursing Father Muller Road Kankanady Mangalore-575002 Karnataka India |
| 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 |
| MsSharmila |
Father Muller Medical College |
Department Of Mental Health Nursing Fourth Floor Father Muller Medical College Hospital Father Muller Road Kankanady Mangalore
FATHER MULLER COLLEGE OF NURSING ,FATHER MULLER CHARITABLE INSTITUTION , FATHER MULLER ROAD, KANKANADY, MANGALORE , KARNATAKA
Dakshina Kannada
KARNATAKA |
8050847001
sharmila@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mandala Coloring |
Administration of Mandala colouring for 30 minutes/day for 6 consecutive days in interventional group. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Male patients with alcohol dependence syndrome
individuals diagnosed with alcohol dependence syndrome with mild to moderate level of anxiety
Who can read and understand Malayalam Kannada and English
|
|
| ExclusionCriteria |
| Details |
Patients with severe anxiety
Patients with poly substance abuse
Those who have chronic mental illness
Critically ill patients
Patient with hospital stay less than 5days
Patients who are intellectually disabled and visually impaired.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After giving the intervention(Mandala Coloring )Individuals diagnosed with alcohol dependence syndrome will reduce anxiety. |
After giving the one week of intervention(Mandala Coloring )Individuals diagnosed with alcohol dependence syndrome will reduce anxiety. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Individuals diagnosed with alcohol dependence syndrome can use the Mandala Coloring to reduce their anxiety |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
17/07/2025 |
| 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) |
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
|
In this study assessing the effect of Mandala Coloring(art therapy) in reducing anxiety among individuals diagnosed with alcohol dependence syndrome. |