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IRCT20250727066647N1 IRCT 2026-07-07 Mazandaran University of Medical Sciences the effects of Mandala coloring on anxiety Investigating the effects of Mandala coloring on anxiety in patients with ulcerative colitis 2026-05-22 anticipated 46 Complete https://irct.ir/trial/85128 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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. N/A Anxiety levels in ulcerative colitis patients. Intervention 1: Intervention group: Patients in the remission phase of ulcerative colitis who, in addition to their usual medical care, perform mandala coloring for 30 minutes a day for 6 consecutive days during their free time. A mandala (from the Sanskrit word meaning "circle") is a geometric, circular, and symmetrical pattern that radiates from a center outward and is used in art therapy as a tool for focusing the mind and reducing tension. Initially, each patient receives a pack of six colored pencils (yellow, blue, green, red, purple, and brown) and 6 sheets of printed mandala designs. The designs are standard circular and symmetrical patterns of moderate complexity, with a different design provided each day. Patients are instructed to sit in a calm environment and complete each design within 30 minutes, with focus and without any restriction on color choice or coloring order. The aim of this activity is to direct the patient's attention toward a simple, repetitive artistic task to promote mental calmness and reduce anxiety. The researcher follows up on the completion of the coloring daily via phone call or text message. Intervention 2: Control group: Ulcerative colitis patients in remission who receive only standard treatments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This is done for the first time and once the results are obtained, a decision is made on how to publish it.
public Mahboobe Ebrahimi
Imam Khomeini Hospital., Amir Mazandarani Street
Sari Iran (Islamic Republic of) 4817718743 +98 11 3434 3250 mahboobeh.ebrahimi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mahboobe Ebrahimi
Imam Khomeini Hospital., Amir Mazandarani Street
Sari Iran (Islamic Republic of) 4817718743 +98 11 3434 3250 mahboobeh.ebrahimi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients in remission phase of ulcerative colitis Between 18 and 60 years old Willingness to participate in the study and provide written consent. Minimum score of 7 on the Hospital Anxiety and Depression Scale questionnaire 18 years 60 years Both Having severe psychological illnesses taking psychiatric medications taking supplements that reduce anxiety Psychological instability (such as bereavement/loss of a loved one) Chronic debilitating disease (such as cancer/diabetes with advanced complications) F41.9 Anxiety disorder, unspecified Other Other Intervention group: Patients in the remission phase of ulcerative colitis who, in addition to their usual medical care, perform mandala coloring for 30 minutes a day for 6 consecutive days during their free time. A mandala (from the Sanskrit word meaning "circle") is a geometric, circular, and symmetrical pattern that radiates from a center outward and is used in art therapy as a tool for focusing the mind and reducing tension. Initially, each patient receives a pack of six colored pencils (yellow, blue, green, red, purple, and brown) and 6 sheets of printed mandala designs. The designs are standard circular and symmetrical patterns of moderate complexity, with a different design provided each day. Patients are instructed to sit in a calm environment and complete each design within 30 minutes, with focus and without any restriction on color choice or coloring order. The aim of this activity is to direct the patient's attention toward a simple, repetitive artistic task to promote mental calmness and reduce anxiety. The researcher follows up on the completion of the coloring daily via phone call or text message. Control group: Ulcerative colitis patients in remission who receive only standard treatments. Anxiety score based on the anxiety subscale of the Hospital Anxiety and Depression Scale. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Mazandaran University of Medical Sciences Approved 2025-07-21 Ethic committee of Imam hospital-Mazandaran University of Medical Science Imam Khomeini Hospital., Amir Mazandarani Street Sari Mazandaran Iran (Islamic Republic of)