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IRCT20231218060451N1 IRCT 2023-12-31 Tabriz University of Medical Sciences Investigating the effectiveness of the virtual reality system compared to routin therapy in the treatment of children with ADHD ADHD Comparison of the Effectiveness of using virtual reality-based training system with routin treatment of ADHD in improving attention and impulsivity of seven to eleven years old children with ADHD 2023-12-31 anticipated 40 Complete https://irct.ir/trial/74510 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research. N/A Attention deficit hyperactivity disorder. Intervention 1: Intervention group: 15 boys and girls will receive virtual reality-based therapy once or twice a week, each session lasting between 60 and 90 minutes and supervised by a psychiatrist. Study for each person will be in 8 sessions for about 2 months. The timing of the sessions is approximately such that the first 10 to 20 minutes are for educating and informing the child and his companion about the therapy sessions, and then another 60 minutes are devoted to performing cognitive behavioral therapy exercises based on virtual reality. Between these exercises, times are considered for rest and children are tested during virtual reality sessions to discover and challenge the power of concentration and attention and control of impulsive behaviors. In this way, in the virtual environment, the child is asked to use his attention and concentration to try to overcome challenges and obstacles, to overcome the stages and to control his impulsive behaviors. Participants are also asked not to do any home exercises between sessions so that the effects of virtual reality therapy can be investigated without the influence of other factors. Then, the effectiveness of each of the treatment methods before and after the intervention will be compared and analyzed in each group and between the two groups. Intervention 2: Control group: 15 boys and girls will receive routine treatment of attention deficit disorder and impulsivity by a psychiatrist. According to the psychiatrist's diagnosis, the control group, which includes 15 subjects aged 7 to 11 years, will be given a standard dosage of half to one mg/kg methylphenedaite. Subjects will be monitored by a psychiatrist for 8 weeks, once a week. 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 .
public Saba Pak'khou
Next to Shahid Madani Medical Education Center, TabrizUniversity Street,
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3177 1006 pakkhou.s@gmail.com Tabriz University of Medical Sciences scientific Saba Pak'khou
Next to Shahid Madani Medical Education Center, University Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3177 1006 pakkhou.s@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of attention deficit and hyperactivity in 7 to 11 years old children by a psychiatrist based on semi-structured K-SAD interview and the diagnostic and statistical criteria of DSM v mental disorders 6 years 12 years Both Having an IQ lower than normal and a score of less than 70 in the Ravan pogressive matrices test Having other disorders and comorbidities diagnosed by psychiatrist based on semi-structured interview K-SAD Unwillingness to cooperate or complete treatment sessions F90 Attention-deficit hyperactivity disorders Treatment - Devices Treatment - Drugs Intervention group: 15 boys and girls will receive virtual reality-based therapy once or twice a week, each session lasting between 60 and 90 minutes and supervised by a psychiatrist. Study for each person will be in 8 sessions for about 2 months. The timing of the sessions is approximately such that the first 10 to 20 minutes are for educating and informing the child and his companion about the therapy sessions, and then another 60 minutes are devoted to performing cognitive behavioral therapy exercises based on virtual reality. Between these exercises, times are considered for rest and children are tested during virtual reality sessions to discover and challenge the power of concentration and attention and control of impulsive behaviors. In this way, in the virtual environment, the child is asked to use his attention and concentration to try to overcome challenges and obstacles, to overcome the stages and to control his impulsive behaviors. Participants are also asked not to do any home exercises between sessions so that the effects of virtual reality therapy can be investigated without the influence of other factors. Then, the effectiveness of each of the treatment methods before and after the intervention will be compared and analyzed in each group and between the two groups. Control group: 15 boys and girls will receive routine treatment of attention deficit disorder and impulsivity by a psychiatrist. According to the psychiatrist's diagnosis, the control group, which includes 15 subjects aged 7 to 11 years, will be given a standard dosage of half to one mg/kg methylphenedaite. Subjects will be monitored by a psychiatrist for 8 weeks, once a week. Attention : This index, which includes visual attention and auditory attention, its overall score is calculated based on the scores of alertness, concentration, and speed indicators, and its value is obtained from performing an integrated visual and auditory test. Timepoint: 60 Days. Method of measurement: Integrated visual and auditory test-2. Vigilance : Ability to maintain and direct attention to the classification of target or non-target stimuli and appropriate response to them. In this study, vigilance is the evaluation of attention, which includes the omission error, and is the average scores obtained from the answers to the questions of the IVA-2 test. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Focus: sustained and stable attention during the test, which indicates the change in the variance of the reaction speed to the correct answers. The evaluation of the variance of the response speed and also the average scores obtained from the answers to the questions of the IVA-2 test. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Speed: It is the reaction time to the correct answers and the speed of mental processing. It is the average reaction time for the correct answers and also the average scores obtained from answering the questions of the IVA-2 test. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Response control: This index, which includes visual response control and auditory response control, is calculated based on the scores of Prudence, Stamina and consistency indicators. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Prudence: Measuring impulsivity and poor response control compared to non-target stimuli. Evaluation of impulsivity/response control, which includes three types of committing errors, and is the average score obtained from the answers to the questions of the IVA-2 test. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Stamina: A measure of overall reliability and variability of response times. It also measures the ability to stay active. Timepoint: 60 Days. Method of measurement: Integrated Visual and Auditory test 2. Consistency: average reaction times to correct answers. Assessment of sustained attention. Average reaction time compares correct responses during the first 200 trials with the last 200 trials. This score is used to identify problems with sustaining attention and effort over time. Timepoint: 60 Days. Method of measurement: Integrated Visual and Auditory test 2. Fine Motor Hyperactivity : The Fine Motor Regulation scale provides additional information by recording off-task behaviours with the mouse, including multiple clicking, spontaneous clicks during instruction periods, anticipatory clicks and holding the mouse button down. In behavioural terms, the Fine Motor Regulation scale quantifies fidgetiness and restlessness associated with small motor hyperactivity. Timepoint: 60Days. Method of measurement: Integrated Visual and Auditory test 2. Tabriz University of Medical Sciences Approved 2021-05-31 The ethics committee of Tabriz university of Medical Science (consultative committee for the protect No. 2, Central Building, Golgasht St, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)