Clinical Trial Study on the Impact of Virtual Reality in Reducing Children's Dental Pain, Fear, and Anxiety

Investigating the effect of virtual reality in reducing pain, fear and anxiety in children during dental procedures

A randomized clinical trial, with a parallel control group, without blinding, a sample size of 60. Randomization using Minitab 17 software.

The research location is a dental office in Kerman city. To compare the effectiveness of using virtual reality (VR) therapy versus usual care for patients. The control group will receive the standard care without any VR content while the intervention group will be treated with VR therapy. Pain, anxiety, and fear levels will be measured through self reports from patients, observations from researchers, and interviews with parents before, during, and after treatment.

Inclusion criteria: No auditory, visual, or speech impairments, require routine dental care. Exclusion criteria: nausea and dehydration, mental disorders, unstable physical or mental health, fear, under four years of age, manifest anxiety, unwilling to participate in the investigation.

During the dental procedure, the intervention group will engage with virtual reality glasses that feature an animation portraying a benevolent woodland lion whose dentition emits mellifluous melodies as it traverses through the arboreal landscape during the seasons of spring, autumn, and winter. Control group: routine care.

Pain, fear and anxiety

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.