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IRCT20190720044281N1 IRCT 2019-12-07 Tehran University of Medical Sciences Effect of computer game on children's anxiety Effect of the Tiny Dentist game on 4 – 10 years old children's anxiety compared with Tell-Show-Do method 2019-06-22 anticipated 100 Complete https://irct.ir/trial/40974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random Allocation - Flip coin method, Blinding description: Blinding of the Outcome Evaluator: Given that the anxiety control method is not included in the evaluation documents (Patient profile, Recorded film of treatment procedure and evaluation paper), the evaluators are unaware of the anxiety control method in each patient. Blinding of Data Analyzer: Considering that the control & intervention groups are distinguished from the each other by number & they are not named, then the analyst is also unaware of which group is control or intervention. N/A Dental Anxiety (This condition is not a disease). Intervention 1: Intervention group: Use of the Tiny Dentist application. Intervention 2: Control group: Tell-Show-Do method. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no base for data publishing regarding information privacy.
public Alireza Heydari
School of dentistry TUMS, North karegar St., Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 a1001heidari@gmail.com Tehran University of Medical Sciences scientific Sara Ghadimi
School of Dentistry TUMS, North Karegar st., Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 sghadimi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 4-10 years old; No dental or medical history; Treatment plan: Oral hygiene education, brushing, infiltration anesthesia, Class II amalgam filling or pulpotomy 4 years 10 years Both Systemic diseases, psychic disorders, physical or mental retardation Teeth pain at visit Children having mobile phone or personal tablets History of playing with the Tiny Dentist application F41 Anxiety Treatment - Other Treatment - Other Intervention group: Use of the Tiny Dentist application Control group: Tell-Show-Do method Anxiety. Timepoint: During Treatment. Method of measurement: Venham-Frankel Anxiety Index. Heart Rate. Timepoint: Before & after anesthesia, before & after intervention, during treatment. Method of measurement: Pulse-oximeter Device. Encountered pain. Timepoint: During treatment. Method of measurement: Wong-Baker index. Tehran University of Medical Sciences Approved 2019-06-01 Ethics in research committee, School of Dentistry, Tehran University of Medical Sciences Tehran University of Medical Sciences, School of dentistry, North karegar Ave., Tehran Tehran Tehran Iran (Islamic Republic of)