Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented reality glasses, VR glasses.
- Who it may be relevant to
- Registry conditions: Dental Anxiety. Basic parameters: 6 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction: Randomized Controlled Clinical Trial
Overview
The aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars.
Interventions
- Device Augmented reality glasses
Augmented reality glasses will be introduced to the child and he will be allowed to choose his favourite cartoon movie from this list: Rapunzel, Stitch, Ratatouille, Frozen, Minions, Zootopia, and The lion king during the first dental visit to get familiar with the AR glasses. The augmented reality is an eye goggle that will be connected to the laptop through a wire, then after playing the cartoon that will be selected by the child on the laptop the child will enjoy watching the cartoon movie th - Device VR glasses
Children allocated to this group will be managed by Virtual reality glasses, which will be introduced to the child and he will be allowed to choose his favourite cartoon from the same list during the first dental visit to get familiar with the VR glasses. The virtual reality is a head-mounted display, the child will be asked to select his favourite cartoon on a mobile, then the mobile will be inserted in that head-mounted display
Primary outcome measures
- Heart rate (HR) assessment [Time frame: Baseline to immediately after the procedure (within the same treatment visit).]
- Anxiety assessment using the Facial Image Scale (FIS) [Time frame: Baseline to immediately after the procedure (within the same treatment visit).]
- Anxiety assessment using Venham's clinical anxiety scale [Time frame: Baseline to immediately after the procedure (within the same treatment visit).]
- Pain assessment using Wong-Baker FACES pain rating scale [Time frame: Baseline to immediately after the procedure (within the same treatment visit).]
- Pain assessment using Face, legs, activity, cry, consolability (FLACC) scale [Time frame: Baseline to immediately after the procedure (within the same treatment visit).]
Eligibility criteria
Inclusion criteria
- Medically free children without visual or auditory impairment (ASA I).
- Children aged 6-8 years.
- Children with Frankl behaviour rating score 3 or 4.
- Children requiring extraction in one of their primary molars.
- Parents who will accept to give their consent and participate in the study
Exclusion criteria
- Children require emergency dental treatment.
- Children with a history of epilepsy and anxiety disorder.
- Children with previous bad dental experience.
- Allergy to local anaesthetic drugs.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07467395 · 1189-11/2025