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IRCT20230829059296N1 IRCT 2023-09-06 Islamic Azad University Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age. Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age. 2023-11-05 anticipated 81 Complete https://irct.ir/trial/72342 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the first stage, samples are selected by convenience sampling. In this way, the samples that met the conditions for entering the study are chosen. In the second stage, the random assignment of samples is done by the random sequence created on the statistical website www.randomizer.org with a ratio of 1:1:1 to three groups of active(fidget spinner game), passive (listening to music), and control so that in each group, 27 people are included. N/A Stress. Intervention 1: Intervention group: Fidget Spinner game group (active entertainment); Patients in this group are introduced to the fidget spinner before the injection, and they are asked to actively participate in this game during the injection of the inferior alveolar block. Intervention 2: Intervention group: group listening to music (passive distraction); The child is asked to listen to the music played through headphones. To minimize bias, instead of allowing children to choose their favorite music, a piece of music was played during the injection. Intervention 3: Control group: No special distraction method is used for them during the injection. 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 No more information
public Niayesh Ebrahimi
No. 4, Saeedi Ave., South Sarrafha Blvd., Saadat Abad
Tehran Iran (Islamic Republic of) 1998863465 +98 21 8868 9828 nia78e@gmail.com Islamic Azad University scientific Sepide Majzoobi
No:4, 10th Neyestan, Pasdaran Ave.
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 se.majzoubi@gmail.com Islamic Azad University Iran (Islamic Republic of) 5 to 10 years old children Inferior Alveolar Nerve Block to be mandatory for dental treatment Obedient children based on Frankel's classification (positive and completely positive) 5 years 10 years Both Previous Dental Experience Current Systemic Disease Current Medically Controlled Psychiatric Disease Hospitalization History Z73.3 Stress, not elsewhere classified Behavior Behavior N/A Intervention group: Fidget Spinner game group (active entertainment); Patients in this group are introduced to the fidget spinner before the injection, and they are asked to actively participate in this game during the injection of the inferior alveolar block. Intervention group: group listening to music (passive distraction); The child is asked to listen to the music played through headphones. To minimize bias, instead of allowing children to choose their favorite music, a piece of music was played during the injection Control group: No special distraction method is used for them during the injection. Changes in oxygen saturation percentage. Timepoint: Before and immediately after injection. Method of measurement: A pulse oximeter device on the finger. Pulse rate changes. Timepoint: Before and immediately after injection. Method of measurement: A pulse oximeter device on the finger. Changes in FACES index. Timepoint: Before and immediately after injection. Method of measurement: FACES index score. Changes in the SEM index. Timepoint: During injection and immediately after injection. Method of measurement: SEM index score. Dental School, Tehran Islamic Azad University Approved 2023-08-05 Ethical Commitee,Deputy of Research , Dental school , Tehran Islamic Azad University No:4; 10th Neyestan; Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)