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IRCT20220123053803N1 IRCT 2022-07-02 Tehran University of Medical Sciences Application vs virtual reality effect on kids fear & anxiety Smartphone application vs virtual reality effect on 5-8years old children fear & anxiety in first dentistry operation 2022-06-22 anticipated 42 Complete https://irct.ir/trial/61529 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done with 4 random blocks and this process is done by someone other than the operator. In this process, Excel software is used and finally the information of each group (virtual reality or application) is placed in closed envelopes and these envelopes are opened only when the operator wants to perform the treatment. There are also possibilities for both types of treatment and it is not clear in advance which treatment is to be performed and the envelopes are numbered in the same order in which they are randomized, Blinding description: Blinding the person who fills in the questionnaires with the child after the treatment and also the person who is responsible for evaluating the questionnaire data. 3 Condition 1: Fear. Condition 2: Anxiety. Intervention 1: The first intervention group is the group that uses virtual reality glasses during the first dental treatment and an animation is played inside the virtual reality glasses so that the child does not get distracted from the surrounding environment and also reduces fear and anxiety during the treatment. Intervention 2: The other group are children who are given the dentist bling game application before the treatment session to play, and this program makes the child familiar with the dental environment and tools so that he experiences less fear and anxiety during the treatment session. 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 It’s not decided yet
public Arman Khosravi Nejad
Unit 14 , No 28 , Afshari Blvd , North Ekhtiarie , Pasdaran
Tehran Iran (Islamic Republic of) 1958743651 +98 21 2277 6304 Armankhosravinezhad@yahoo.com Tehran University of Medical Sciences scientific Arman Khosravi Nejad
Unit 14 , No 28 , Afshari Blvd , North Ekhtiarie , Pasdaran
Tehran Iran (Islamic Republic of) 1958743651 +98 21 2277 6304 Armankhosravinezhad@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Co-operative kids (not in group Frankl's class 1 and in group 2-3-4) First dentistry operation 5-8years 5 years 8 years Both Pulpectomy / extraction / Restoration / abscess indication Systemic disease F40.23 F06.4 Blood, injection, injury type phobia Anxiety disorder due to known physiological condition Treatment - Devices Treatment - Devices The first intervention group is the group that uses virtual reality glasses during the first dental treatment and an animation is played inside the virtual reality glasses so that the child does not get distracted from the surrounding environment and also reduces fear and anxiety during the treatment. The other group are children who are given the dentist bling game application before the treatment session to play, and this program makes the child familiar with the dental environment and tools so that he experiences less fear and anxiety during the treatment session. Comparison of virtual reality and application on anxiety index. Timepoint: While first dentistry operation. Method of measurement: Facial Anxiety Scale / Modified Child Dental Anxiety Scale. Comparison of virtual reality and applications on the fear index. Timepoint: While first dentistry operation. Method of measurement: Dental Subscale Children's Fear Survey Schedule. Tehran University of Medical Sciences Approved 2022-01-10 ethics committee of Tehran University of Medical Sciences تهران، اتوبان نواب، ابتدای خانی آباد نو، خیابان ماهان(شهید زلفی)، روبروی پارک شریعتی، دانشکده دندانپزشکی پردیس بین الملل Tehran Tehran Iran (Islamic Republic of)