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IRCT20240609062052N4 IRCT 2024-10-10 Khomein University of medical sciences The effectiveness of mandala coloring on the sleep quality of hemodialysis patients The effectiveness of mandala coloring on the sleep quality of hemodialysis patients in dialysis centers affiliated to Khomein University of Medical Sciences 2024-10-22 anticipated 41 Complete https://irct.ir/trial/79302 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, random blocks will be used in order to hide the randomized allocation (concealment) and balance (balance) during and after the study. By using the sealedenvelope site and based on the sample size, people will be randomly placed in blocks of 4 and 6. The randomized list will be available only to the researcher as an Excel file. N/A Condition 1: Chronic kidney disease. Condition 2: Acute kidney failure. Condition 3: Unspecified kidney failure. Intervention 1: Intervention group: In the intervention group, for 4 sessions during 4 days in 2 weeks (two consecutive dialysis sessions per week), a mandala design will be done daily and during dialysis for 30 to 60 minutes. In total, 4 identical plans are used for all people, but the use of plans in each session is at the discretion of the participants And in fact, in each meeting, they can choose and color one of the 4 available designs. It is better to paint at the beginning of the morning and after waking up due to higher concentration. It is suggested to use colored pencils from outside to inside. For this purpose, each participant will be given a box of 6 colored pencils. Intervention 2: Control group: In the control group, there is no intervention, and only the sleep quality of people like the intervention group will be measured at the beginning and end of the study (before and after the intervention). Yes - There is a plan to make this available What will be shared: All information and data will be shared after de-identifying people. When: Access will start 1 month after the results are published. To whom: All people related to medical and health matters Conditions: The use of data will only be subject to mention of the source of the study and the authors. It is definitely necessary to obtain permission from the authors and researchers of the study. Where to obtain: With this email: mahdisafarabadi@gmail.com How to obtain: After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester. Comments:
public Mahdi Safar Abadi
Quds square,khomein faculty of medical sciences
khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences scientific Mahdi Safar Abadi
Quds square,khomein faculty of medical sciences
khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences Iran (Islamic Republic of) At least 6 months of hemodialysis experience Consent to participate in the research Literacy at least reading and writing 18 years no limit Both A history of neurodegenerative disease The inability of the patient to continue participating in the research for any reason Not wanting to continue cooperation Changing the treatment method to peritoneal dialysis or kidney transplant. Transferring to other medical centers N18 N17 N19 Chronic kidney disease (CKD) Acute kidney failure Unspecified kidney failure Other N/A Intervention group: In the intervention group, for 4 sessions during 4 days in 2 weeks (two consecutive dialysis sessions per week), a mandala design will be done daily and during dialysis for 30 to 60 minutes. In total, 4 identical plans are used for all people, but the use of plans in each session is at the discretion of the participants And in fact, in each meeting, they can choose and color one of the 4 available designs. It is better to paint at the beginning of the morning and after waking up due to higher concentration. It is suggested to use colored pencils from outside to inside. For this purpose, each participant will be given a box of 6 colored pencils. Control group: In the control group, there is no intervention, and only the sleep quality of people like the intervention group will be measured at the beginning and end of the study (before and after the intervention). Sleep quality. Timepoint: The results are evaluated twice, once before the intervention from the time they entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). Khomein University of medical sciences Approved 2024-09-24 Ethics Committee of Khomein Faculty of Medical Sciences Azadi Avenue Khomein Markazi Iran (Islamic Republic of)