]>
IRCT20250906067136N1 IRCT 2025-09-09 Islamic Azad University Comparison of the Effectiveness of Neurofeedback and Yoga on Enhancing Concentration, Attention, and Reducing Anxiety in Children Aged 6 to 11 with Attention-Deficit/Hyperactivity Disorder (ADHD) Comparison of the Effectiveness of Neurofeedback and Yoga on Enhancing Concentration, Attention, and Reducing Anxiety in Children Aged 6 to 11 with Attention-Deficit/Hyperactivity Disorder (ADHD) 2025-09-23 anticipated 50 Complete https://irct.ir/trial/86031 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A simple randomization method will be used. According to this method, the names of all selected participants will be written on pieces of paper and placed in a box for a lottery draw. Then, the pieces of paper will be drawn one by one, with the first 25 participants (1–25) assigned to the experimental group and the next 25 participants (26–50) drawn from the box assigned to the control group. N/A Attention-Deficit/Hyperactivity Disorder. Intervention 1: Intervention group: The intervention group will participate in a 24-session training program, each session lasting 60 minutes (30 minutes of neurofeedback + 30 minutes of yoga), conducted three times per week. 1. Sessions 1–3: Introduction and Initial AssessmentGoal: Reduce initial anxiety, familiarize children with the treatment process, and enhance motivation.Content:Neurofeedback: Baseline EEG assessment, introduction to the device, and simple games.Yoga: Introduction to yoga in child-friendly language, practice of abdominal breathing, and simple stretches.Homework: Daily 3-minute abdominal breathing exercise with parents. 2. Sessions 4–6: Beginning Basic TrainingGoal: Strengthen sustained attention and increase body awareness.Content:Neurofeedback: Implementation of SMR protocol (12–15 Hz), simple visual games.Yoga: Cat–cow, tree pose, and basic arm–leg stretches combined with calm breathing.Homework: Daily practice of the tree pose or a simple stretch at home. 3. Sessions 7–9: Stabilization and RelaxationGoal: Improve mental and physical self-regulation.Content:Neurofeedback: Continuation of SMR training with calm breathing before each session.Yoga: Focus on breathing and simple seated–standing movements.Homework: Daily 5-minute calm breathing practice with parents. 4. Sessions 10–12: Enhancing Selective AttentionGoal: Improve processing speed and focus on specific stimuli.Content:Neurofeedback: Introduction of low beta protocol (15–18 Hz), intermediate-level games.Yoga: Animal poses (frog, snake, bird) combined with storytelling.Homework: Practice one animal yoga pose at home and perform it for parents. 5. Sessions 13–15: Strengthening Sustained AttentionGoal: Enhance accuracy and mind–body control.Content:Neurofeedback: Combined SMR + beta protocol, more engaging games.Yoga: Balance exercises (tree pose, warrior, standing on one foot).Homework: Daily one-leg balance for 20 seconds. 6. Sessions 16–18: Training in Simulated ConditionsGoal: Generalize learned skills to real-life situations.Content:Neurofeedback: Practice with distracting stimuli (additional sounds or images).Yoga: Guided relaxation (simple body scan, lying down, and breathing).Homework: Relaxation practice before bedtime (lying down and calm breathing). 7. Sessions 19–21: Review and IntegrationGoal: Automate attention and integrate mind–body skills.Content:Neurofeedback: Advanced-level games, focusing under more difficult conditions.Yoga: Integration of breathing, stretches, animal poses, and balance exercises.Homework: Short yoga session at home (5 minutes breathing + 2 simple poses). 8. Sessions 22–24: Final ConsolidationGoal: Consolidate achievements and transfer skills into daily life.Content:Neurofeedback: Final review and training, reassessment of changes.Yoga: Review of learned movements, final playful yoga session.Homework: Continue daily practice (5 minutes breathing + one focus activity or yoga pose). Intervention 2: Control group: They receive no training. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the primary outcome or similar, can be shared. When: Access period begins 6 months after publication of results. To whom: The data will only be accessible to researchers affiliated with academic or scientific institutions. Conditions: Any type of analysis is permitted on the delivered data. Where to obtain: Via email: sogand.shahwar@aui.ir How to obtain: The data will be sent after emailing sogand shahwar and receiving approval from the research team members. Comments:
public Sogand Shahwar
No. 26, Arad 6 Building, Mehregan 4, Sepidar
Ahvaz Iran (Islamic Republic of) 617773751 +98 61 3227 1486 sogand.shahwar@aui.ir Islamic Azad University scientific Rahmatollah Khanmohammadi
South Kargar Boulevard, Farhang Shahr District, Golestan Highway
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8421 info@iauahvaz.ac.ir Islamic Azad University Iran (Islamic Republic of) Having a confirmed diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) by the school counselor as well as through ADHD questionnaires. The child’s age should be between 6 and 11 years (completed). Having an Intelligence Quotient (IQ) within the normal range (typically 90–110 or higher), as measured by the Wechsler Intelligence Scale for Children (WISC-IV). No use of psychiatric medications during the past three months. Obtaining written informed consent from the child’s parents for participation in the study. 6 years 11 years Both Presence of severe comorbid psychiatric disorders or serious comorbid conditions such as psychotic disorders, severe major depressive disorder, bipolar disorder, or autism spectrum disorders. Presence of neurophysiological disorders such as a history of epilepsy, seizures, severe head trauma, or any known neurological condition that may affect brain function and EEG. Regular participation of the child in other psychotherapy sessions (such as play therapy, art therapy) or any other interventions that directly affect attention and anxiety during the study period. Presence of severe sensory (blindness, deafness) or motor impairments that make participation in yoga sessions or sitting still during neurofeedback sessions impossible. Lack of willingness of the child or family to consistently comply with the research protocol (regular attendance at sessions, completing questionnaires) or their request to withdraw from the study at any stage. F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Behavior N/A Intervention group: The intervention group will participate in a 24-session training program, each session lasting 60 minutes (30 minutes of neurofeedback + 30 minutes of yoga), conducted three times per week. 1. Sessions 1–3: Introduction and Initial AssessmentGoal: Reduce initial anxiety, familiarize children with the treatment process, and enhance motivation.Content:Neurofeedback: Baseline EEG assessment, introduction to the device, and simple games.Yoga: Introduction to yoga in child-friendly language, practice of abdominal breathing, and simple stretches.Homework: Daily 3-minute abdominal breathing exercise with parents. 2. Sessions 4–6: Beginning Basic TrainingGoal: Strengthen sustained attention and increase body awareness.Content:Neurofeedback: Implementation of SMR protocol (12–15 Hz), simple visual games.Yoga: Cat–cow, tree pose, and basic arm–leg stretches combined with calm breathing.Homework: Daily practice of the tree pose or a simple stretch at home. 3. Sessions 7–9: Stabilization and RelaxationGoal: Improve mental and physical self-regulation.Content:Neurofeedback: Continuation of SMR training with calm breathing before each session.Yoga: Focus on breathing and simple seated–standing movements.Homework: Daily 5-minute calm breathing practice with parents. 4. Sessions 10–12: Enhancing Selective AttentionGoal: Improve processing speed and focus on specific stimuli.Content:Neurofeedback: Introduction of low beta protocol (15–18 Hz), intermediate-level games.Yoga: Animal poses (frog, snake, bird) combined with storytelling.Homework: Practice one animal yoga pose at home and perform it for parents. 5. Sessions 13–15: Strengthening Sustained AttentionGoal: Enhance accuracy and mind–body control.Content:Neurofeedback: Combined SMR + beta protocol, more engaging games.Yoga: Balance exercises (tree pose, warrior, standing on one foot).Homework: Daily one-leg balance for 20 seconds. 6. Sessions 16–18: Training in Simulated ConditionsGoal: Generalize learned skills to real-life situations.Content:Neurofeedback: Practice with distracting stimuli (additional sounds or images).Yoga: Guided relaxation (simple body scan, lying down, and breathing).Homework: Relaxation practice before bedtime (lying down and calm breathing). 7. Sessions 19–21: Review and IntegrationGoal: Automate attention and integrate mind–body skills.Content:Neurofeedback: Advanced-level games, focusing under more difficult conditions.Yoga: Integration of breathing, stretches, animal poses, and balance exercises.Homework: Short yoga session at home (5 minutes breathing + 2 simple poses). 8. Sessions 22–24: Final ConsolidationGoal: Consolidate achievements and transfer skills into daily life.Content:Neurofeedback: Final review and training, reassessment of changes.Yoga: Review of learned movements, final playful yoga session.Homework: Continue daily practice (5 minutes breathing + one focus activity or yoga pose). Control group: They receive no training. Attention-Deficit/Hyperactivity. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Integrated Visual and Auditory Continuous Performance Test. Children's Anxiety. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Spence Children's Anxiety Scale - SCAS. Attention-Deficit/Hyperactivity. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Swanson, Nolan, and Pelham Rating Scale – Fourth Edition (SNAP-IV). Islamic Azad University Approved 2025-09-03 The Ethics Committee in Research of Islamic Azad University - Ahvaz Branch South Kargar Boulevard, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)