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IRCT20210710051836N3 IRCT 2023-05-14 Kerman University of Medical Sciences The Impact of Virtual Reality in Reducing Children's Dental Pain, Fear, and Anxiety Clinical Trial Study on the Impact of Virtual Reality in Reducing Children's Dental Pain, Fear, and Anxiety 2023-04-03 anticipated 60 Complete https://irct.ir/trial/69984 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The process of random assignment, whereby participants are divided into control and intervention groups without bias, was facilitated through the use of Minitab 18 software. This program generates a series of random numbers which we utilized to allocate individuals to their respective groups. The aim of this approach is to prevent any predictions regarding the type of intervention received by both the company providers and researchers. We enter a series of numbers as the number of sample size in the first column and after the Calc tab, we click the sample from column option and we say, give us the numbers we entered in a random form, which does this by sampling without placement. In order to achieve the random order of entry of people into each of the groups under study, first in the software and in the first column, we create an arithmetic sequence of numbers starting from 1 and ending at 60 (the number of the required sample size). Then, because the ratio of people in both groups is equal, through the mentioned path, we inform the software that the number of 50% or half of the numbers in the first column is placed in the two columns with the names of the control group and the intervention group. In this way, we have two sets of random numbers that can be used in the order in which people enter each group, for example, the column of the intervention group has random numbers 3, 4, and 7, which means it is the third. The fourth and seventh patients who refer to the office are included in the intervention group. N/A Palpectomy. Intervention 1: Intervention group: The intervention is scheduled to utilize virtual reality headsets during their dental operation. These devices are designed specifically for children and feature a captivating animation depicting a benevolent woodland predator, whose dentition produces melodious sounds as it traverses through the seasonal transitions of autumn, spring, and summer. Intervention 2: Control group: The control group experiences the dental procedure without virtual reality glasses. 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 After consulting with the experts participating in this project, a decision will be made on publishing or not publishing
public Houriyeh Ehtemam
Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 003431325415 h.ehtemam@gmail.com Kerman University of Medical Sciences scientific Houriyeh Ehtemam
Haft Bagh Alavi
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5415 h.ehtemam@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) No vision problems No hearing problem No speech problems The need for routine dental treatment 4 years 15 years Both The child displays a heightened level of anxiety Age under four years The child and her parents exhibited a lack of willingness to partake in the study Having symptoms such as nausea Having symptoms such as dehydration Use of sedatives Psychopathy Unstable state of physical or mental health Fear Rehabilitation Rehabilitation Intervention group: The intervention is scheduled to utilize virtual reality headsets during their dental operation. These devices are designed specifically for children and feature a captivating animation depicting a benevolent woodland predator, whose dentition produces melodious sounds as it traverses through the seasonal transitions of autumn, spring, and summer. Control group: The control group experiences the dental procedure without virtual reality glasses. Pain. Timepoint: Since the inception of the research investigation. Method of measurement: Wong-Baker FACES (WBS) Pain Rating Scale. Fear. Timepoint: Since the inception of the research investigation. Method of measurement: The Child Fear Scale (CFS). Anxiety. Timepoint: Since the inception of the research investigation. Method of measurement: Faces version of Modified Child Dental Anxiety Scale (MCDAS (f)), SCARED (parent version) and The Children’s Anxiety Meter-State (CAM-S). Kerman University of Medical Sciences Approved 2023-03-15 Kerman University of Medical Sciences Deputy of Research, Jahad Blvd, Kerman Kerman Kerman Iran (Islamic Republic of)