Effect of Augmented Reality on Dental Anxiety and Pain Perception in Children
NCT Number: NCT06530654
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Pain
Interventions: BEHAVIORAL: Distraction by dentist|BEHAVIORAL: Distraction by cartoon movie|BEHAVIORAL: AG-active distraction group
Sponsor: Istanbul University
Collaborators: Istanbul Technical University
Sex: ALL
Age: CHILD
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2025-05-20
Locations: Istanbul University, Faculty of Dentistry, Department of Pedodontics, Istanbul, Turkey

Summary:
The aim of this study is to reduce dental anxiety in children by using augmented reality (AG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.

The effectiveness of augmented reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with AG. In the course of these experiments, the effects of AG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of AG on the level of stress on dental treatment.

Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.

Primary Outcome Measures: Child's anxiety assessment (objective), In order to determine the stress levels of the children included in the study, cortisol, α-Amylase and CHGA levels in saliva will be measured, 1 year
Secondary Outcome Measures: Child's anxiety assessment (objective), Heart rate is used to determine the anxiety levels of all treated children at certain critical moments of the treatment being. Significant differences in heart rate is compared between groups., 1 year|Child's anxiety assessment (subjective), Scores on the Modified Child Dental Anxiety Scale, MCDAS(f) scale may range from 8 to 40, with scores below 19 indicating absence of state anxiety, scores higher than 19 indicating the pres- ence of state anxiety and scores higher than 31, in- dicating severe phobic disorder, 1 year|Child's pain assessment (subjective), The Wong-Baker Faces Pain Rating Scale is a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst., 1 year|Child's behaviour assessment (subjective) Child's pain assessment (subjective), According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist)., 1 year