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临床试验/CTRI/2026/01/102294
CTRI/2026/01/102294尚未招募不适用

Calming Colours: Exploring the Biological effect of Mandala Colouring Using Electroencephalography (EEG) and Heart Rate Variability (HRV) in Depression

Indian Coucil of Medical Research1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年2月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
56
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of Depression with Single episode or Recurrent depressive disorder diagnosed as per ICD -11 and Hamilton Depression Rating Scale score greater than 7
  • Adults aged 18 to 50 years, of any gender
  • Willingness to participate and provide informed consent.
  • Able to understand Hindi or English.

排除标准

  • Patients with Psychotic symptoms
  • Any other psychiatric diagnosis including substance abuse, Intellectual disability, sensory or physical impairment
  • Patients with any co-morbid medical illness
  • Patients on any relaxation exercise, yoga, and art therapy practice.

研究者

发起方
Indian Coucil of Medical Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dhairya Chaniyara

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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