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IRCT20190703044082N13 IRCT 2025-10-10 Hamedan University of Medical Sciences Comparison of the effect of virtual reality-based games and cartoon watching on anxiety, fear, and pain in children with acute lymphoblastic leukemia during chemotherapy Comparison of the effect of virtual reality-based games and cartoon watching on anxiety, fear, and pain in children with acute lymphoblastic leukemia during chemotherapy 2025-09-23 anticipated 93 Complete https://irct.ir/trial/85454 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For random allocation into three groups (playing with virtual reality, watching cartoons with virtual reality, and control), a block randomization method with blocks of 6 will be used. This method involves creating 20 blocks of 6 units each (60 combinations), with each block including two participants for each group. The three letters A (playing with virtual reality), B (watching cartoons with virtual reality), and C (control) are written on pieces of paper and placed in an envelope. The random order of drawing the letters determines the groups, for example, A for playing with virtual reality, B for watching cartoons with virtual reality, and C for control. Then, 20 blocks of six-letter combinations such as AABBCC and ABCABC are written on paper and placed in an envelope. The blocks are selected randomly with replacement. Children are assigned to groups based on the order of the selected blocks. N/A cancer. Intervention 1: Intervention group: In group A (virtual reality game): First, a 3D game suitable for the child's gender and interests is selected. Then, the game is started using virtual reality glasses 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). Pain intensity, fear, and anxiety will be assessed 10 minutes before chemotherapy, during chemotherapy, and immediately after chemotherapy. Intervention 2: Intervention group: Intervention group: In group B (watching cartoons with virtual reality): First, a 3D cartoon suitable for the child's gender and interests is selected. Then, watching the cartoon using virtual reality glasses begins 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy. Intervention 3: Control group: In group C (control): No virtual reality-based intervention is received. However, children can use routine activities such as playing or watching movies with their parents' mobile phones, but these activities will be without virtual reality technology. The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy. 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 further information
public Fateme Mohammadi
Hamadan University of Medical sciences, Khajeh Rashid Blvd
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3334 5634 mohammadifateme47@yahoo.com Hamedan University of Medical Sciences scientific Fateme Mohammadi
Hamadan University of Medical sciences, Khajeh Rashid Blvd
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3334 5634 mohammadifateme47@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Acute lymphoblastic leukemia Age 6 to 12 years First course of chemotherapy No speech, vision, or hearing disorders, or mental retardation No neurological deficits affecting pain perception based on medical records In stage one (Induction Phase) or stage two (Consolidation Phase) of cancer Under treatment with L-asparaginase Willingness to participate in the study Non-dominant arm line is fixed. 6 years 12 years Both Reluctance to continue the study process Development of poisoning from chemotherapy drugs Occurrence of emergency situations such as cardiopulmonary resuscitation or seizure, etc Not playing games or watching with virtual reality glasses for more than 10 minutes Treatment - Other Treatment - Other Treatment - Other Intervention group: In group A (virtual reality game): First, a 3D game suitable for the child's gender and interests is selected. Then, the game is started using virtual reality glasses 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). Pain intensity, fear, and anxiety will be assessed 10 minutes before chemotherapy, during chemotherapy, and immediately after chemotherapy. Intervention group: Intervention group: In group B (watching cartoons with virtual reality): First, a 3D cartoon suitable for the child's gender and interests is selected. Then, watching the cartoon using virtual reality glasses begins 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy. Control group: In group C (control): No virtual reality-based intervention is received. However, children can use routine activities such as playing or watching movies with their parents' mobile phones, but these activities will be without virtual reality technology. The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy. Pain intensity. Timepoint: Before starting chemotherapy, during chemotherapy, and after completing chemotherapy. Method of measurement: Oucher Pain Scale. Fear. Timepoint: Before starting chemotherapy, during chemotherapy, and after completing chemotherapy. Method of measurement: Children's Fear Scale. Anxiety. Timepoint: Before starting chemotherapy, during chemotherapy, and after completing chemotherapy. Method of measurement: Visual-Facial-Anxiety-Scale. Hamadan University of Medical Sciences Approved 2025-09-22 Research ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical sciences, Khajeh Rashid Blvd Hamadan Hamadan Iran (Islamic Republic of)