CTRI Number |
CTRI/2019/01/017276 [Registered on: 28/01/2019] Trial Registered Prospectively |
Last Modified On: |
28/01/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Other |
Public Title of Study
|
Mandala art therapy,new rehabilatative stategy for intellectually disables |
Scientific Title of Study
|
Effect of Mandala Art Therapy on attention and functional social skill among intellectually disabled children in a selected special school of Udupi, Karnataka |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pooja Bakshi |
Designation |
Student MSc 2nd year Psychiatric Nursing |
Affiliation |
Manipal College of Nursing Manipal |
Address |
Department of Psychiatric Mental Health Nursing
Manipal College of Nursing Manipal
MAHE, Manipal Manipal College Of Nursing, Manipal, Manipal Academy
Of Higher Education, Manipal, Karnataka Madhav Nagar, Eshwar
Nagar, Manipal, Udupi, Karnataka 576104
Udupi Udupi KARNATAKA 576104 India |
Phone |
9836825660 |
Fax |
|
Email |
poo.pooja.bakshi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Pooja Bakshi |
Designation |
Student MSc 2nd year Psychiatric Nursing |
Affiliation |
Manipal College of Nursing Manipal |
Address |
Department of Psychiatric Mental Health Nursing
Manipal College of Nursing Manipal
MAHE, Manipal Manipal College Of Nursing, Manipal, Manipal Academy
Of Higher Education, Manipal, Karnataka Madhav Nagar, Eshwar
Nagar, Manipal, Udupi, Karnataka 576104
Udupi Udupi KARNATAKA 576104 India |
Phone |
9836825660 |
Fax |
|
Email |
poo.pooja.bakshi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Pooja Bakshi |
Designation |
Student MSc 2nd year Psychiatric Nursing |
Affiliation |
Manipal College of Nursing Manipal |
Address |
Department of Psychiatric Mental Health Nursing
Manipal College of Nursing Manipal
MAHE, Manipal Manipal College Of Nursing, Manipal, Manipal Academy
Of Higher Education, Manipal, Karnataka Madhav Nagar, Eshwar
Nagar, Manipal, Udupi, Karnataka 576104
Udupi Udupi KARNATAKA 576104 India |
Phone |
9836825660 |
Fax |
|
Email |
poo.pooja.bakshi@gmail.com |
|
Source of Monetary or Material Support
|
Pooja Bakshi, MSc. Nursing second year student, MCON, Manipal, MAHE, Manipal
|
|
Primary Sponsor
|
Name |
Pooja Bakshi |
Address |
Manipal College of Nursing, Manipal, MAHE, Manipal
|
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 |
Mrs Jaya Vijaya |
Asha Nilaya School and Vocational Rehabilitation Centre for Mentally Challenged |
Near Lombard Memorial Hospital
Shanthinagar, Udupi 576101.
KARNATAKA
(no room number or department) Udupi KARNATAKA |
0820-2523380
ashaschool1981@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: F70||Mild intellectual disabilities, (2) ICD-10 Condition: F71||Moderate intellectual disabilities, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Attention and Functionl Social skil |
USING Attention Rating sxcale, Single Letter Cancellation Test, Functionl socio-vocational assessment scale |
Intervention |
Mandala Art Therapy |
Predrawn Mandalas will be given which are to be coloured and filled in. As therapy progressess the design detaliling increases. |
|
Inclusion Criteria
|
Age From |
5.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
Mild and moderately Intellectually disabled children present at the time of data collection. |
|
ExclusionCriteria |
Details |
Children with severe and profound intellectually disabl
Children with elated mood, violent behavior, blind or deaf or physical disability
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Increased attebtion and concentration and improved social skills |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
Not applicable |
|
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)
|
30/01/2019 |
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="1" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Mandalas are recently introduced in modern world of psychiatric health. But it is the more westernized version which can be used as a psychotherapy. Mandala art therapy is used as relaxation or as a tool for meditation, used to enhance insight and individuation, healing of self and helps in expression of self and unconscious mind. The purpose of the study is to assess the effectiveness of Mandala Art Therapy among intellectually disabled children with regard to increase the attention and functional social skills thereby helping the children with intellectual disability to improve learning ability and social skills. This study is to assess the effect of mandala art therapy on mild and moderately intellectually disabled children. Fristly t ools on attention and functional social skill and socio demographic proforma will be administered on the first day, then pre-drawn mandalas will be given. Then the participants have to fill in the colors. The session will be for an hour and it will be given three times a week for 4 weeks. At the end of the 4 weeks the same tools will be re-administered. The difference between pre-test post-test scores will be analysed for evaluation of the effects.A study done on students of International Islamic University in Islamabad, Pakistan to assess the effectiveness of Mandala coloring as a therapeutic intervention for reducing anxiety among 100 university students by using state trait anxiety inventory. The researcher used State-Trait Anxiety Inventory to measure anxiety level among 100 university students within the age range of 18-34 years. The student’s anxiety level was assessed before and after coloring a pre-drawn Mandala. The results suggested significant difference in pre-test and post-test scores, with a t value = 8.91 which concluded that Mandala coloring as a therapeutic intervention in reducing anxiety. (Sarah Mehmood Noor, Mandala colouring as a therapeutic intervention for Anxiety reduction in University students, 2017) A study done on students of International Islamic University in Islamabad, Pakistan to assess the effectiveness of Mandala coloring as a therapeutic intervention for reducing anxiety among 100 university students by using state trait anxiety inventory. The researcher used State-Trait Anxiety Inventory to measure anxiety level among 100 university students within the age range of 18-34 years. The student’s anxiety level was assessed before and after coloring a pre-drawn Mandala. The results suggested significant difference in pre-test and post-test scores, with a t value = 8.91 which concluded that Mandala coloring as a therapeutic intervention in reducing anxiety. (Sarah Mehmood Noor, Mandala colouring as a therapeutic intervention for Anxiety reduction in University students, 2017) Mandalas are recently introduced in modern world of psychiatric health. But it is the more westernized version which can be used as a psychotherapy. Mandala art therapy is used as relaxation or as a tool for meditation, used to enhance insight and individuation, healing of self and helps in expression of self and unconscious mind. The purpose of the study is to assess the effectiveness of Mandala Art Therapy among intellectually disabled children with regard to increase the attention and functional social skills thereby helping the children with intellectual disability to improve learning ability and social skills.This study is to assess the effect of mandala art therapy on mild and moderately intellectually disabled children. Fristly t ools on attention and functional social skill and socio demographic proforma will be administered on the first day, then pre-drawn mandalas will be given. Then the participants have to fill in the colors. The session will be for an hour and it will be given three times a week for 4 weeks. At the end of the 4 weeks the same tools will be re-administered. The difference between pre-test post-test scores will be analysed for evaluation of the effects.A study done on students of International Islamic University in Islamabad, Pakistan to assess the effectiveness of Mandala coloring as a therapeutic intervention for reducing anxiety among 100 university students by using state trait anxiety inventory. The researcher used State-Trait Anxiety Inventory to measure anxiety level among 100 university students within the age range of 18-34 years. The student’s anxiety level was assessed before and after coloring a pre-drawn Mandala. The results suggested significant difference in pre-test and post-test scores, with a t value = 8.91 which concluded that Mandala coloring as a therapeutic intervention in reducing anxiety. (Sarah Mehmood Noor, Mandala colouring as a therapeutic intervention for Anxiety reduction in University students, 2017) A study done on students of International Islamic University in Islamabad, Pakistan to assess the effectiveness of Mandala coloring as a therapeutic intervention for reducing anxiety among 100 university students by using state trait anxiety inventory. The researcher used State-Trait Anxiety Inventory to measure anxiety level among 100 university students within the age range of 18-34 years. The student’s anxiety level was assessed before and after coloring a pre-drawn Mandala. The results suggested significant difference in pre-test and post-test scores, with a t value = 8.91 which concluded that Mandala coloring as a therapeutic intervention in reducing anxiety. (Sarah Mehmood Noor, Mandala colouring as a therapeutic intervention for Anxiety reduction in University students, 2017) |