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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 tools 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 tools 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) 

 
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