]>
IRCT20191225045896N1 IRCT 2020-05-18 Shahid Chamran University of Ahvaz Investigating the effectiveness of pain’s cognitive-behavioral therapy and its computerized version in the reduction of pain intensity, depression, anger and anxiety in children with cancer. Investigating the effectiveness of pain’s cognitive-behavioral therapy and its computerized version in the reduction of pain intensity, depression, anger and anxiety in children with cancer 2018-01-07 anticipated 50 Complete https://irct.ir/trial/45146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Balanced block randomization, Blinding description: The Participants were not aware of the type of intervention of other groups, and the aim objective of the study. The Intervention’s evaluators did not know the purpose of the study. N/A Condition 1: Cancer. Condition 2: َAnxiety. Condition 3: Depression. Condition 4: Anger. Condition 5: Pain. Intervention 1: The first experimental group: Six sessions of cognitive-behavioral therapy in terms of private sessions for each participant were held weekly. The first session included a review of the rules of the meetings (i.e., the principle of anonymity, timely attendance, and assignments), cancer education tutorials and changes which cancer has made in the activities, the introduction of a sensory thermometer to measure the degree of emotion, the introduction to the meetings’ processes and the skills which were to be learned ,next session’s assignments, and the last part of the session which was a fun activity with the therapist. The second session included the review of the assignments the investigation of the challenges and possible problems, introducing Pain Gate Control Theory and the factors which help closing the pain gates, abdominal breathing exercises, relaxation exercises, next session’s assignments, and the last part of the session which was a Pleasurable activity with the therapist. The third session included the review of the assignments, statements on the relationships of thought, feeling, behavior and cognitive errors, positive self-esteem and cognitive reconstructions, reinforcement and self-rewarding, the subsequent session’s homework, the last part of the session which was performing a fun activity. The fourth section included The review of the challenges, problem solving training, attention deviation strategies training, positive mental imagery, countdown), next session’s assignments, and the last part of the session which was doing a fun activity. The fifth session included the review of the assignment, anger control, effective communication training, and next session’s assignment. The last part of the session which was doing one pleasant activity with the therapist. The sixth session included reviewing the pre-treatment task, activating the behavior, presenting the instruction booklet, and a summary of the practical treatment tips, and doing a fun activity with the therapist as the final part of the session. Intervention 2: The second experimental group’s intervention included using computer training software and performing its tasks on a weekly basis. This version included a compact disc (including 6 sessions) and a parents’ manual and handbook designed as a computer program. The program is a computer program consisting of educational materials which are in accordance with the educational content similar to in-person intervention designed based on prior research. The program was designed and developed by the researchers. The program includes sections on psycho-education, animation, and computer games. The participant inserted the CD into the computer or laptop and then observed the contents of each session according to the instructions in the manual. At the beginning of the program, a list of sessions was specified on the page where they could see the content of that meeting by clicking on the icon of each session. Meanwhile, they performed a series of assignments in the booklet. At the end of each session, after viewing the training material and performing the assignments, the student could play one or more computer games on his/ her own choice. In the computer version, all of the above mentioned materials were provided as an educational program in the form of animation with a manual. Each week the participants observed a part of the program and performed the exercises related to that part. Intervention 3: The control group: They received no intervention. However, at the end of the treatment sessions of the experimental groups, the control group received the computer program for ethical considerations. No - There is not a plan to make this available Justification or reason for not sharing IPD is Research colleagues disagree
public Vajihe Hamedi
No.385, Shahid Kolahdoz(Dolat)Ave,
Tehran Iran (Islamic Republic of) 1939714956 +98 21 2264 6848 v.hamedi@gmail.com Shahid Chamran University of Ahvaz scientific Vajiheh Hamedi
No.385, Shahid Kolahdoz (Dolat) Ave,
Tehran Iran (Islamic Republic of) 1939714956 +98 21 2264 6848 v.hamedi@gmail.com Shahid Chamran University of Ahvaz Iran (Islamic Republic of) They were 9-12 years old. They were literate They had one type of cancer. They were fluentluency in Persian. 8 years 12 years Both They had neuro-developmental disorders They had autism spectrum disorders (according to the diagnosis of a psychiatrist). They had a history of seizure. F06.4 R45.4 G89.18 Anxiety disorder due to known physiological condition Irritability and anger Other acute postprocedural pain Behavior Behavior Other The first experimental group: Six sessions of cognitive-behavioral therapy in terms of private sessions for each participant were held weekly. The first session included a review of the rules of the meetings (i.e., the principle of anonymity, timely attendance, and assignments), cancer education tutorials and changes which cancer has made in the activities, the introduction of a sensory thermometer to measure the degree of emotion, the introduction to the meetings’ processes and the skills which were to be learned ,next session’s assignments, and the last part of the session which was a fun activity with the therapist. The second session included the review of the assignments the investigation of the challenges and possible problems, introducing Pain Gate Control Theory and the factors which help closing the pain gates, abdominal breathing exercises, relaxation exercises, next session’s assignments, and the last part of the session which was a Pleasurable activity with the therapist. The third session included the review of the assignments, statements on the relationships of thought, feeling, behavior and cognitive errors, positive self-esteem and cognitive reconstructions, reinforcement and self-rewarding, the subsequent session’s homework, the last part of the session which was performing a fun activity. The fourth section included The review of the challenges, problem solving training, attention deviation strategies training, positive mental imagery, countdown), next session’s assignments, and the last part of the session which was doing a fun activity. The fifth session included the review of the assignment, anger control, effective communication training, and next session’s assignment. The last part of the session which was doing one pleasant activity with the therapist. The sixth session included reviewing the pre-treatment task, activating the behavior, presenting the instruction booklet, and a summary of the practical treatment tips, and doing a fun activity with the therapist as the final part of the session. The second experimental group’s intervention included using computer training software and performing its tasks on a weekly basis. This version included a compact disc (including 6 sessions) and a parents’ manual and handbook designed as a computer program. The program is a computer program consisting of educational materials which are in accordance with the educational content similar to in-person intervention designed based on prior research. The program was designed and developed by the researchers. The program includes sections on psycho-education, animation, and computer games. The participant inserted the CD into the computer or laptop and then observed the contents of each session according to the instructions in the manual. At the beginning of the program, a list of sessions was specified on the page where they could see the content of that meeting by clicking on the icon of each session. Meanwhile, they performed a series of assignments in the booklet. At the end of each session, after viewing the training material and performing the assignments, the student could play one or more computer games on his/ her own choice. In the computer version, all of the above mentioned materials were provided as an educational program in the form of animation with a manual. Each week the participants observed a part of the program and performed the exercises related to that part. The control group: They received no intervention. However, at the end of the treatment sessions of the experimental groups, the control group received the computer program for ethical considerations. Pain score in Jung and Baker's scale. Timepoint: Before the intervention, the last session of the intervention, one month after the intervention. Method of measurement: Jung and Baker's pain scale. Spilberger's State -Trait Anxiety Scale. Timepoint: Before the intervention, the last session of the intervention, one month after the intervention. Method of measurement: Spilberger's State -Trait Anxiety Scale. Children's Depression Inventory Score. Timepoint: Before the intervention, the last session of the intervention, one month after the intervention. Method of measurement: Children's Depression Inventory. Spilberger's State-Trait-Anger Expression Inventory score. Timepoint: Before the intervention, the last session of the intervention, one month after the intervention. Method of measurement: Spilberger's State-Trait-Anger Expression Inventory. Shahid Chamran University of Ahvaz Approved 2018-01-06 Ethics Committee for Research in Ahvaz Jundishapur University Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)