Investigatig the effect of mandala coloring on the anxiety of children candidates for tonsillectomy

General purpose: to determine the effect of mandala coloring on anxiety caused by tonsillectomy

This study will be conducted as a clinical trial, with a control group and an intervention group, without blinding, simple randomization, on 60 patients through convenient sampling methods.

This study will be conducted on 60 patients referred for tonsillectomy surgery to Imam Khomeini Hospital (RA) in Khomein city. In the intervention group, the samples will be colored for 30-45 minutes using 10 colors of colored pencils to color the raw mandala sample. After completing the coloring, the Spence questionnaire will be filled again by the participants.

Inclusion criteria Age 8 to 15 Satisfaction of the patient and the patient's parents Obtaining a score higher than 84% in the Spence anxiety test and exclusion criteria Lack of cooperation of the patient and parents patient restlessness

After completing the Spence questionnaire, in the intervention group, the samples will be asked to paint a raw mandala (25 x 17 dimensions) using 10 colored pencils for 30-45 minutes; No special action will be taken in the control group

Reducing anxiety caused by tonsillectomy

Sampling was carried out using convenience sampling and purposive sampling based on the study’s inclusion criteria. Subsequently, the participants were assigned into intervention and control groups through a simple randomization method. For the simple randomization procedure, 60 rows of numbers were entered into SPSS software (version 27). Then, using the commands Data, Select Cases, Random sample of cases, the software was instructed to randomly select 50% of the cases. The selected 50% were assigned to the intervention group, while the remaining 50% (unselected cases) were considered as the control group. During patient enrollment, and in accordance with the randomization process performed by the software, the sequence of allocation was as follows: the first three admitted patients were assigned to the intervention group, the next four patients to the control group, the following two patients to the intervention group, the next four patients to the control group, one patient to the intervention group, the next patient to the control group, the subsequent patient to the intervention group, the next patient to the control group, the following six patients to the intervention group, two patients to the control group, and so forth until the 60th patient (the last patient recruited according to the calculated sample size) was allocated.

Only de-identified data relevant to the primary outcomes of the study will be shared upon request.

Data will be available starting 6 months after the publication of the study results.

Qualified researchers and postgraduate students in the related field

For academic and clinical research purposes aimed at improving healthcare outcomes and reducing anxiety in the studied population, under appropriate ethical approval.

To the principal investigator at Islamic Azad University, Khomein Branch

If someone requests the data or documentation of the study, they must send a written request via email to the principal investigator. Upon review and approval by the research team, and if necessary, after obtaining approval from the Ethics Committee, the de-identified data will be shared with the requester. This process may take between 2 to 4 weeks.