Effectiveness of Virtual Reality Glasses in Reducing Dental Anxiety among 6-12-year-old Children with Moderate to Severe Hearing and Speech Disorders : A clinical trial with two parallel groups

Determining the effectiveness of virtual reality glasses in reducing dental anxiety in children aged 6 to 12 with moderate to severe hearing and speech disorders Under the Coverage of the Golestan Welfare Organization

A randomized clinical trial with a control group and parallel groups, unblinded. Randomization was done using block randomization of size four, stratified by gender and age, combining intervention and control groups

In the dental school of Gorgan, eight samples will be collected daily using block random sampling with a size of 4, selecting randomly from six patterns (AABB, ABAB, ABBA, BAAB, BABA, BBAA) twice a day. Two treatment groups will undergo fluoride therapy and prophylaxis on both jaws. A sign language interpreter may be used for communication with children. The first group will receive VR glasses before treatment, with carefully selected cartoon content to avoid excessive excitement. The tell-feel-show-do method will be applied before treatment in both groups. Anxiety levels will be measured with a visual analog scale (0-10) using images of varying facial expressions, and children’s blood pressure (systolic and diastolic) and heart rate will be recorded before, during, and after treatment. Results will be compared across different stages.

Children aged 2 to 12 years with moderate to severe hearing and speech disorders, no previous dental visits, child cooperation at levels three and four of the Frankl scale (positive and definitely positive cooperation), absence of systemic problems, and parental consent for fluoride treatment.

Treatment in the intervention group is performed using virtual reality glasses. In the control group, treatment will be performed without the use of virtual reality glasses.

Heart Rate, Blood Pressure, Visual Analog Scale

32 children will be assigned considering age and gender to prevent the effect of age and gender in two groups, ages 6-9 and 9-12, and two genders, boys and girls. The study will be designed so that on four different days, eight samples each day (on the first day, eight boys aged 6-9, on the second day, eight girls aged 6-9, on the third day, eight boys aged 9-12, on the fourth day, eight girls aged 9-12) will be carried out using block random sampling with a size of 4 and a combination of two techniques A and B in groups of 4 according to the following pattern. Thus, in each stage, one of the patterns from 1 to 6 will be selected randomly with replacement and this will continue until the total samples are reached. Each day, one of the six patterns AABB-ABAB-ABBA-BAAB-BABA-BBAA will be randomly chosen twice. In group A, the treatment will be conducted with VR glasses, while in group B, the treatment will take place without VR glasses.