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IRCT20251213068299N1 IRCT 2025-12-25 Gonabad University of Medical Sciences "The Effect of Mandala-Style Coloring on Cognitive Function in the older adults" "The Effect of Mandala-Style Coloring on Cognitive Function in the older adults" 2026-01-14 anticipated 42 Complete https://irct.ir/trial/88132 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: They will be assigned to two intervention and control groups using four-way permutation blocks.for this purpose, the intervention group will be assigned the letter A and the control group will be assigned the letter B. The possible states in the four-state block of six states include AABB, BBAA, ABAB, BABA, ABBA, BAAB, each state will be written on a card and assigned to cards numbered one to six. Then, one of the six possible states will be selected using dice and the selected patients will be divided into two groups based on that. This process will continue until the sample size is completed. N/A Mild Cognitive Impairment. Intervention 1: Intervention group: Coloring mandala designs with 6 colored pencils, twice a week for 20 minutes for up to two months. Intervention 2: Control group: Free coloring with black pencil without a specific pattern twice a week in 20-minute sessions for up to two months. Yes - There is a plan to make this available What will be shared: Due to ethical considerations and to maintain the confidentiality of participant information, individual data from this study cannot be shared publicly. However, aggregated, de-identified data will be available upon request and with the approval of the lead researcher. When: The period of access to de-identified documents and data begins 6 months after the publication of the final results of the thesis, and this access will be maintained for 5 years. To whom: Requests for access to data are only possible by researchers working in reputable academic and research centers, and will be made after reviewing the research purpose and with the approval of the responsible researcher and the ethics committee. Conditions: Access to data is subject to a formal request with a specific research purpose, and data use is permitted only for scientific, non-commercial purposes and within the framework of the stated goals. Confidentiality of information, no attempt to re-identify individuals, and final approval by the responsible researcher are mandatory. Where to obtain: Applicants can submit their formal request through correspondence with the researcher responsible for the project via the email address listed in the IRCT system and, after review and approval, proceed to receive non-identifiable documents or data. How to obtain: After submitting the official request, the request will be reviewed by the responsible researcher within a maximum of 2 to 4 weeks, and if approved, de-identified data will be provided to the applicant. Comments: There are no further details regarding data sharing.
public Zohre Nazari
Next to the Asian Road
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 4946 zohrenazari1402@gmail.com Gonabad University of Medical Sciences scientific Hossein Ajam Zibad
Next to the Asian Road, Faculty of Nursing, Gonabad University of Medical Sciences.
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3814 moallef@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the research and providing written consent to participate in the research. Having mild cognitive impairment (based on studies, a score of 24 (sometimes 23-25) is suspicious of cognitive impairment on the Montreal Cognitive Assessment Questionnaire). Absence of severe mental disorders or advanced dementia (based on family statements). Having the necessary physical and mental ability to perform the coloring activity. The ability to see and recognize mandala designs. Ability to communicate. No chronic diseases. Avoid taking medications that affect memory and cognitive function. No previous experience in coloring mandalas. Having at least basic reading and writing skills. 60 years no limit Both Physical or psychological problems that may prevent staining from occurring during the study. Unwillingness to continue research. Absence from more than two intervention sessions. Starting medications that affect cognitive function. The coloring process may cause significant stress or anxiety for the elderly person. G31.84 Mild Cognitive Impairment, so stated Behavior Behavior Intervention group: Coloring mandala designs with 6 colored pencils, twice a week for 20 minutes for up to two months. Control group: Free coloring with black pencil without a specific pattern twice a week in 20-minute sessions for up to two months. Cognitive Function Of Older Adult. Timepoint: Before And After Intervention. Method of measurement: Montreal Cognitive Assessment Test. Gonabad University of Medical Sciences Approved 2025-12-08 Ethics Committee of Gonabad University of Medical Sciences Imam Khomeini Street, Ghadir Square, Gonabad. Gonabad Razavi Khorasan Iran (Islamic Republic of)