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CTRI Number  CTRI/2026/01/102294 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mandala art]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   The Effects of Mandala Colouring on Brain waves and Heart rate in Depression 
Scientific Title of Study   Calming Colours: Exploring the Biological effect of Mandala Colouring Using Electroencephalography (EEG) and Heart Rate Variability (HRV) in Depression 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhairya Chaniyara 
Designation  MBBS Student 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  MIA Basni Phase-2 Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9313347078  
Fax    
Email  dhairyavc1212@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijay Kumar Saini 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  MIA Basni Phase2 Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9460869846  
Fax    
Email  vsaini344@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dhairya Chaniyara 
Designation  MBBS Student 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  MIA Basni Phase2 Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9313347078  
Fax    
Email  dhairyavc1212@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur 
 
Primary Sponsor  
Name  Indian Coucil of Medical Research 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhairya Chaniyara  All India Institute of Medical Sciences Jodhpur   Department of Psychiatry and Physiology Room no 146
Jodhpur
RAJASTHAN 		 9313347078

dhairyavc1212@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Clinical Trial AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colouring Mandala  Participants in the intervention group will be provided with pre-printed mandala sheets and a colouring set containing 12 colours. Participants will be instructed to complete two mandalas per week one per day on two separate days spending a minimum of 20 minutes on each session for 4 weeks. 
Comparator Agent  Control group  Patients in this group will receive standard pharmacotherapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients of Depression with Single episode or Recurrent depressive disorder diagnosed as per
ICD -11 and Hamilton Depression Rating Scale score greater than 7
2. Adults aged 18 to 50 years, of any gender
3. Willingness to participate and provide informed consent.
4. Able to understand Hindi or English. 
 
ExclusionCriteria 
Details  1. Patients with Psychotic symptoms
2. Any other psychiatric diagnosis including substance abuse, Intellectual disability, sensory
or physical impairment
3. Patients with any co-morbid medical illness
4. Patients with Cognitive impairment.
5. Patients on any relaxation exercise, yoga, and art therapy practice. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Chanage in Depression rating scale, EEG and HRV  2 week and 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   18/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to email ID dhairyavc1212@gmail.com

  6. For how long will this data be available start date provided 21-10-2025 and end date provided 21-10-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is ICMR STS project with aim to assess Effectiveness of Mandala coloring in patients with depression and to compare biological changes (EEG & HRV) after first and last session (at 4 week) of mandala colouring . 
After applying the inclusion and exclusion criteria, participants in the study will be divided into two groups. At the beginning, they will be given the option to engage in mandala colouring as an adjunctive activity. Those who choose to participate in the mandala colouring will be placed in the intervention group, receiving antidepressant medications (preferably Selective Serotonin Reuptake Inhibitor- SSRI) along with the colouring activity. Those who decline will be assigned to the control group, receiving only antidepressant medications (preferably SSRI). Participants in the intervention group will be provided with pre-printed mandala sheets and a colouring set containing 12 colours. Participants will be instructed to complete two mandalas per week—one per day on two separate days—spending a minimum of 20 minutes on each session. Over a 4-week period, participants will complete a total of 8 mandalas. Follow-up assessments will be conducted at 2 and 4 weeks. In Intervention group, EEG and HRV measurements will be recorded at baseline, immediately after the first colouring session, and at the conclusion of the fourth week (following the final mandala session). For control group, EEG and HRV will be recorded at baseline and at 4 weeks. Hamilton Depression rating scale (HDRS) will be used to assess severity of depression at Baseline, 2 week and 4 week. Changes in HDRS , EEG and HRV will be done at same points of time.  
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