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IRCT20210501051142N8 IRCT 2023-01-30 Arak University of Medical Sciences The Effect of Mandala Coloring on anxiety and hopelessness The Effect of Mandala Coloring on anxiety and hopelessness in children with cancer 2023-03-01 anticipated 98 Complete https://irct.ir/trial/68227 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: children are assigned to groups in the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and does not have a specific pattern, and its arrangement is completely random. To assign the samples to two groups, the block randomization method will be used with a block size of 4, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the two groups. First, all the states where two letters A and B can be arranged together in a block of 2 are created, and a block is randomly selected by placing it between the blocks, and from the arrangement pattern in that block for Child allocation is used then this block will be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in, Blinding description: The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement. N/A Anxiety. Intervention 1: Intervention group: The demographic information form and the anxiety and hopelessness questionnaire are completed by children in collaboration with the researcher before the intervention in both groups. Coloring will be done only for the intervention group. The method of coloring and participating in the study will be fully explained by the researcher and the children in the intervention group are asked to start coloring a mandala design selected from the mandala coloring book by Alberta Hutchinson in a private and quiet place. Coloring is done for six sessions, every day of the week, and each session lasts a maximum of 30 minutes. After the intervention, the anxiety and hopelessness questionnaire is completed again by children in collaboration with the researcher in both groups. Intervention 2: Control group: They do not receive this intervention during this period. After the intervention, the anxiety and hopelessness questionnaire is completed again by children in collaboration with the researcher in both groups. Yes - There is a plan to make this available What will be shared: Only the part of the data related to the original outcome will be able to be shared. When: since the spring of 2023 To whom: Researchers and students in this field Conditions: In order to reduce the anxiety and despair of children suffering cancer. Where to obtain: Vice chancellor for education and research, Arak university of medical sciences How to obtain: These documents will be available on the website of Arak university of medical sciences. Comments:
public Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Having the ability to paint Age over 8 years to 18 years Suitable general condition Pass at least one course of chemotherapy 8 years 18 years Both Suffering from anxiety and obsessive disorders Existence of acute stressful conditions during the last six months Genetic disease in child F06.4 Anxiety disorder due to known physiological condition Other Other Intervention group: The demographic information form and the anxiety and hopelessness questionnaire are completed by children in collaboration with the researcher before the intervention in both groups. Coloring will be done only for the intervention group. The method of coloring and participating in the study will be fully explained by the researcher and the children in the intervention group are asked to start coloring a mandala design selected from the mandala coloring book by Alberta Hutchinson in a private and quiet place. Coloring is done for six sessions, every day of the week, and each session lasts a maximum of 30 minutes. After the intervention, the anxiety and hopelessness questionnaire is completed again by children in collaboration with the researcher in both groups. Control group: They do not receive this intervention during this period. After the intervention, the anxiety and hopelessness questionnaire is completed again by children in collaboration with the researcher in both groups. Average anxiety score. Timepoint: Coloring will be done for six sessions, every day of the week and each session will last a maximum of 30 minutes. Method of measurement: At the beginning and end of the study, a demographic questionnaire and a anxiety questionnaire are completed by the children with the cooperation of the researcher in both groups and based on this, the level of anxiety of the children is determined. Frustration. Timepoint: Coloring will be done for six sessions, every day of the week and each session will last a maximum of 30 minutes. Method of measurement: At the beginning and end of the study, the demographic questionnaire and the frustration questionnaire are completed by the children with the cooperation of the researcher in both groups, and based on this, the level of frustration of the children is determined. Arak University of Medical Sciences Approved 2022-12-11 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)