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IRCT20221102056383N2 IRCT 2025-09-01 Islamic Azad University Determining the effect of mandala coloring on the anxiety Investigatig the effect of mandala coloring on the anxiety of children candidates for tonsillectomy 2024-08-21 anticipated 60 Complete https://irct.ir/trial/78253 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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. N/A Anxiety caused by tonsillectomy. Intervention 1: Intervention group: The samples are asked to color a raw mandala sample measuring 25×17 for 30-45 minutes using 10 colored pencils. It should be noted that in this study, 5 designs are used, and the participants will choose one of them according to their taste. After the intervention, the Spence Child Anxiety Scale will be completed by the participants in the intervention group. Intervention 2: Control group: No intervention was performed in this group and they will simply complete the questionnaire. Yes - There is a plan to make this available What will be shared: Only de-identified data relevant to the primary outcomes of the study will be shared upon request. When: Data will be available starting 6 months after the publication of the study results. To whom: Qualified researchers and postgraduate students in the related field Conditions: For academic and clinical research purposes aimed at improving healthcare outcomes and reducing anxiety in the studied population, under appropriate ethical approval. Where to obtain: To the principal investigator at Islamic Azad University, Khomein Branch How to obtain: 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. Comments:
public Zeynab Beheshti
Islamic Azad University, Khomein Branch, University Town, Daneshgah Boulevard, Shohada-ye Daneshjoo Boulevard
Khomein Iran (Islamic Republic of) ۳۸۸۱۵۱۷۱ +98 86 4634 3493 zeynabbeheshti7941@yahoo.com Islamic Azad University, Khomein Branch scientific Zeynab Beheshti
Islamic Azad University, Khomein Branch, University Town, Daneshgah Boulevard, Shohada-ye Daneshjoo Boulevard
Khomein Iran (Islamic Republic of) ۳۸۸۱۵۱۷۱ +98 86 4634 3493 zeynabbeheshti7941@yahoo.com Islamic Azad University, Khomein Branch Iran (Islamic Republic of) Age between 8 and 15 years Consent of the patient and the patient’s parents Score higher than 84% on the Spence Anxiety Test 8 years 15 years Both Suffering from severe psychiatric disorders Severe visual or motor impairments that interfere with the ability to perform coloring activities Inability to establish basic verbal communication with the therapist or researcher Use of anxiolytic or other stable psychiatric medications within the past three months Other Other Intervention group: The samples are asked to color a raw mandala sample measuring 25×17 for 30-45 minutes using 10 colored pencils. It should be noted that in this study, 5 designs are used, and the participants will choose one of them according to their taste. After the intervention, the Spence Child Anxiety Scale will be completed by the participants in the intervention group. Control group: No intervention was performed in this group and they will simply complete the questionnaire. Average anxiety score. Timepoint: Before and after the intervention, mandala coloring. Method of measurement: At the beginning of the study, a demographic questionnaire and Spence questionnaire were completed, and after the mandala coloring was completed, the Spence questionnaire was completed again, and based on this, the patients' anxiety level was determined. Islamic Azad University Approved 2024-07-10 Research Ethics Committees of Islamic Azad University- Aligudarz branch Islamic Azad University, Aligoudarz Branch, Daneshgah Square Aligudarz Lorestan Iran (Islamic Republic of)