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IRCT20210501051142N2 IRCT 2021-12-01 Arak University of Medical Sciences The effect of expressive writing on anxiety in children with cancer undergoing chemotherapy The effect of expressive writing on anxiety in children with cancer undergoing chemotherapy 2021-12-22 anticipated 88 Complete https://irct.ir/trial/59547 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Children are assigned to one intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 2 and 4 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the two groups. First, all the modes in which the 2 letters A, B can be put together in blocks of 2 and 4 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate children. Finally this block will be placed in the main container and another block will be selected again. Blocks of 2 and 4 will all be in the same container. All this will be done with software called Matlab . 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 outcome assessor 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: Participants write in a private and quiet place, regardless of the grammar, about their deepest feelings and thoughts about the illness and the treatments performed for their illness. The time and date of writing the expressive writing are written at the top of the handwriting sheet. Writing is 3 times, each time for at least 15 minutes and no limit on the number of sentences and 1 expressive writing is written per week on the day of chemotherapy. The intervention will last for 3 weeks for each patient. Intervention 2: Control group: In this group, no intervention is performed, the control group receives only routine therapeutic care. 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 2022 To whom: Researchers and students in this field Conditions: To reduce anxiety in children during chemotherapy and in order to develop a comprehensive program aimed at the psychological healing of children with cancer and with interventions such as those related to the anxiety of children with cancer or studies related to the factors affecting the mood of children with cancer, researchers can use the results of this study in these areas. 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) Definitive diagnosis of any cancer by a specialist doctor Diagnosis of anxiety with a higher score of 35 using the Spence questionnaire Children hospitalized and have a record in a medical center Have a minimum literacy Suitable general condition to the extent that she/he is able to participate in the study Pass at least one course of chemotherapy 9 years 15 years Both Existence of acute stressful conditions during the last six months History of psychotropic and drug use during the last six months Genetic disease in children Other Other Intervention group: Participants write in a private and quiet place, regardless of the grammar, about their deepest feelings and thoughts about the illness and the treatments performed for their illness. The time and date of writing the expressive writing are written at the top of the handwriting sheet. Writing is 3 times, each time for at least 15 minutes and no limit on the number of sentences and 1 expressive writing is written per week on the day of chemotherapy. The intervention will last for 3 weeks for each patient. Control group: In this group, no intervention is performed, the control group receives only routine therapeutic care. Anxiety rate. Timepoint: Anxiety of each patient is measured before the intervention and immediately after the intervention, 1 month and 3 months after the intervention. Method of measurement: Anxiety is measured by the Spence Children's Anxiety Scale. Arak University of Medical Sciences Approved 2021-09-19 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)