Investigating the effects of Mandala coloring on anxiety in patients with ulcerative colitis

Studying the effects of Mandela coloring on anxiety in patients with ulcerative colitis

A randomized, parallel-group clinical trial was conducted on 46 patients with ulcerative colitis; simple randomization was performed in a 1:1 ratio using a random number table

Patients are selected by faculty members at the Sari Gastroenterology and Liver Research Center. The patients' anxiety levels are measured using the Hospital Anxiety and Depression Scale questionnaire. Anxious individuals are divided into two intervention and control groups using a random number table. The intervention group colors the Mandala on a page daily for 6 days, and then the patients' anxiety levels are measured after 6 days.

Inclusion criteria: Patients with ulcerative colitis aged 18 to 60 years with a minimum score of 7 based on the Hospital Anxiety and Depression Scale questionnaire who are in clinical remission, with written consent. Exclusion criteria: Severe psychiatric illness, Psychological instability, Chronic debilitating disease, taking psychiatric medications, taking supplements that reduce anxiety

The intervention group, in addition to their usual care, will do mandala coloring for 30 minutes a day for 6 consecutive days during their free time. Initially, each patient will receive a pack of six colored pencils (yellow, blue, green, red, purple, and brown) and 6 sheets of printed mandala designs. The control group will consist of patients who will receive only usual care.

Anxiety score based on the anxiety subscale of the Hospital Anxiety and Depression Scale questionnaire

Randomization method: Simple randomization. Each patient is assigned to one of the two groups with equal probability, independently of the allocation of other patients. Unit of randomization: Individual (each patient is the unit of randomization). Randomization strata: Stratified randomization was not used. Randomization tool: Random sequence generation software (Random Allocation Software) for generating the sequence and opaque, sealed, consecutively numbered envelopes for allocation and concealment. Sequence generation: The random sequence is generated before the start of the study by a person independent of the research team (who has no role in screening or assessing patients), using Random Allocation Software, with a 1:1 allocation ratio for 46 patients. Allocation concealment: Based on the generated sequence, the same independent person prepares 46 opaque, sealed, and consecutively numbered envelopes, each containing the name of the allocated group. After confirming eligibility and obtaining written consent, the researcher opens the next envelope in the order patients enroll and assigns each patient to the intervention or control group according to its content. The person who generated the sequence has no involvement in patient enrollment or assignment in order to maintain allocation concealment.