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IRCT20210101049901N1 IRCT 2021-04-07 Arak University of Medical Sciences The effect of board games on cancer anxiety and fatigue The effect of board games on anxiety and fatigue of adolescents with leukemia 2021-01-20 anticipated 66 Complete https://irct.ir/trial/53433 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to the existence of two separate wards in Mahak Medical Center to prevent the dissemination of information between the two groups, one ward will be randomly assigned to the control group and the other to the intervention group. To do so, wards numbers will be written on two separate balls and will be placed inside a bag. The control group is assigned to the first piked ball and while the remaining ball represents the intervention group. The researcher will play in groups with 4-6 persons which are subbranches of the intervention group. It should be noted that these two wards are not distinguished in terms of hospitalizing physicians, physical space, and type of patients. patients will be randomly allocated to the control or intervention group with the help of 4 block randomization created with SPSS during the admission. To do so, the hospital admission will contact the researcher during patient reception to determine the patient ward based on the prepared SPSS list. To prepare the SPSS list, first in the "variable" section, a variable named ID is created, then the "compute variable" is chosen in the "transform" toolbar. In the "Compute variable" window, "ALL" is chosen for the "function group" and "Casenum" for the "function and special variables". Next, the "A" varialble is created based on the 0.1+(casenum/4)-0.49 formula. The "A" parameter is Rounded by choosing the "Rnd(1)" option in the "function and special variables" sub-window to create the "B" parameter. In the next step, a "random number" with a "uniform" distribution between 0-1 is created. After that, "the Rank case" is chosen in the "transform" toolbar, and the "uniform" variable is ranked based on the "B" variable. As a result, in the created variable, numbers 1.0 and 2.0 represent the control group, and 3.0 and 4.0 represent the intervention. N/A Fatigue and anxiety in adolescents with leukemia. Intervention 1: Intervention group: adolescents in the intervention group will be divided into groups of 4-6 people. A training session will be held to teach them how to play the games. In the intervention group, the researcher will play board games 75 minutes per day for 4 days (1 game every 2 days) including mafia and "chicken milk" in the game room. The researcher will play the role of facilitator in the playing games. In the "chicken milk" game, the players should define a product with the help of cards they receive. Then, they have to present their product to other players and persuade them to buy it. Mafia game is an interactive game based on the discussion between players. The players will be categorized into two groups of mafias and civilians by the cards they receive randomly. The civilians should identify mafia group members by cooperating with each other. At the beginning of the study, pre-tests will be taken from both groups based on questionnaires. After 4 days, post-tests will be taken from both groups with questionnaires. Intervention 2: Control group: medicine and existing pamphlets in the Mahak Hospital will be considered as routine care in both groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Derakshan
Qom - Zeindodin - Zolfaghar 1` N 18
Qom Iran (Islamic Republic of) 3713197773 32707520 kosar1171@gmail.com Arak University of Medical Sciences scientific Fatemeh Derakshan
Zeindodin - Zolfaghar 1 N18
Qom Iran (Islamic Republic of) 3713197773 +98 25 3270 7520 kosar1171@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Experience at least 1 course of chemotherapy Diagnosis of cancer based on medical records Adolescent hospitalization for treatment 11 years 19 years Both Mental illness based on adolescent medical records Treatment - Other Treatment - Other Intervention group: adolescents in the intervention group will be divided into groups of 4-6 people. A training session will be held to teach them how to play the games. In the intervention group, the researcher will play board games 75 minutes per day for 4 days (1 game every 2 days) including mafia and "chicken milk" in the game room. The researcher will play the role of facilitator in the playing games. In the "chicken milk" game, the players should define a product with the help of cards they receive. Then, they have to present their product to other players and persuade them to buy it. Mafia game is an interactive game based on the discussion between players. The players will be categorized into two groups of mafias and civilians by the cards they receive randomly. The civilians should identify mafia group members by cooperating with each other. At the beginning of the study, pre-tests will be taken from both groups based on questionnaires. After 4 days, post-tests will be taken from both groups with questionnaires. Control group: medicine and existing pamphlets in the Mahak Hospital will be considered as routine care in both groups. Fatigue mark based on the "cancer related fatigue" questionnaire. Timepoint: Before and after intervention. Method of measurement: Iranian Version of Cancer-Related Fatigue questionnaire. Anxiety marks based on Hospital Anxiety and Depression Scale (HADS). Timepoint: Before and after intervention. Method of measurement: Anxiety section in the Hospital Anxiety and Depression Scale (HADS). Arak University of Medical Sciences Approved 2020-12-13 Ethics Committee of Arak University of Medical Sciences Shahid Zainuddin - Zulfiqar 1, No. 18 Qom Ghoum Iran (Islamic Republic of)