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CTRI Number  CTRI/2026/03/105474 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 05/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mandala Art ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effectiveness of mandala art in reducing pregnancy related anxiety and quality of life among primiparous mother at selected hospital in Bangalore 
Scientific Title of Study   Effectiveness of Mandala art as an intervention in alleviating pregnancy related anxiety and quality of life among primiparous mother at selected hospital in Bangalore 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Sadikshya Neupane  
Designation  7th Semester BSc Nursing Student  
Affiliation  Krupanidhi College of Nursing  
Address  Department of Nursing Krupanidhi college of Nursing 12/1, Chikka Bellandur, Carmelaram Post Varthur Hobli, Off Sarjapur Road

Bangalore
KARNATAKA
560035
India 
Phone  9019357284  
Fax    
Email  sadikshyan34@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Shasikala  
Designation  Associate Professor  
Affiliation  Krupanidhi College of Nursing  
Address  Department of Nursing Krupanidhi college of Nursing 12/1, Chikka Bellandur, Carmelaram Post Varthur Hobli, Off Sarjapur Road

Bangalore
KARNATAKA
560035
India 
Phone  9036166512  
Fax    
Email  shasikalavenkat19031987@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mrs Shasikala  
Designation  Associate Professor  
Affiliation  Krupanidhi College of Nursing  
Address  Department of Nursing Krupanidhi college of Nursing 12/1, Chikka Bellandur, Carmelaram Post Varthur Hobli, Off Sarjapur Road

Bangalore
KARNATAKA
560035
India 
Phone  9036166512  
Fax    
Email  shasikalavenkat19031987@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi university of Health Sciences 12, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 
 
Primary Sponsor  
Name  Rajiv Gandhi university of Health Sciences  
Address  12, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 
Type of Sponsor  Other [Univeristy ] 
 
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 Prabha Lis Thomas  Natus Hospital   Dept of Administrative office ground floor, Room no 2, 20/13, Sarjapura - Marathahalli Rd, Carmelaram, Janatha Colony, Doddakannelli, Bengaluru, Karnataka 560035
Bangalore
KARNATAKA 		 9886451011

prabhapadanilam02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RV COLLEGE OF NURSING  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mandala art therapy   Participants assigned to the intervention group will receive eight standardized mandala designs along with coloured felt tip pens provided by researcher. They will be instructed to draw and colour mandala daily in a calm environment for a minimum of 30 minutes per session at a time and completing 8 mandala design over a period of four weeks. The same mandala designs will be uniformly provided to all participants to ensure standardization of the intervention. Participants may continue beyond 30 minutes if desired. Adherence to the intervention will be assessed by reviewing the completed mandala designs at the time of post-intervention data collection. 
Comparator Agent  Standard antenatal care   Standard antenatal care  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primiparous mother
who have not received mandala art training or therapy before.
who is willing to participate voluntary in the study.
 
 
ExclusionCriteria 
Details  Primiparous mother
• who are visually impaired and physically disabled.
• with pre-existing mental illness /undergoing counselling.
• who are diagnosed with any pregnancy related medical ailments like gestational diabetes, preeclampsia, placental abnormalities, hydramnios.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Pregnancy related anxiety and quality of life   baseline, after 4 weeks of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL  
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   20/03/2026 
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="0"
Months="3"
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  

Mandala art, a structured colouring activity involving circular symmetrical patterns, is a simple, non-pharmacological intervention shown to reduce stress and anxiety. However, limited evidence exists regarding its effectiveness in improving quality of life during pregnancy, particularly in Indian settings.

This study is a single-blind randomized controlled trial conducted among primiparous mothers attending the antenatal clinic at Natus Hospital, Bengaluru. Eligible participants will be randomly allocated into intervention and control groups. The intervention group will colour standardized mandala designs daily for 30 minutes over four weeks, in addition to routine antenatal care. The control group will receive routine antenatal care alone.

Pregnancy-related anxiety will be assessed using the Pregnancy-Specific Anxiety Tool (PSAT), and quality of life will be measured using the Indian Pregnant Women Quality of Life Index (IPW-QOLI), at baseline and post-intervention.

The study aims to compare the effectiveness of mandala art versus routine care on pregnancy-related anxiety and quality of life among primiparous mothers and to examine its association with selected demographic variables. Findings may provide evidence for incorporating low-cost, non-pharmacological interventions into routine antenatal care to improve maternal psychological well-being.

The study is expected to demonstrate that primiparous mothers who practice mandala art in addition to routine antenatal care will show a statistically significant reduction in pregnancy-related anxiety scores compared to those receiving routine care alone. It is also anticipated that the intervention group will report a significant improvement in overall quality of life, particularly in psychological and social domains. The findings are expected to support mandala art as a simple, low-cost, non-pharmacological intervention that can be integrated into routine antenatal care to promote maternal mental well-being and potentially contribute to improved maternal outcomes.

 
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