Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorSara Hazem Mohamed Rabie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Augmented reality glasses

    Device

    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 through the eye goggle.

  • VR glasses

    Device

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Augmented RealityExperimental treatment 1 intervention
Group B: Virtual RealityActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate (HR) assessment

Heart rate (HR) will be employed as an anxiety indicator, as stress or anxiety can increase it. It will be measured using a pulse oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger.

Time frame
Baseline to immediately after the procedure (within the same treatment visit).
2

Anxiety assessment using the Facial Image Scale (FIS)

The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.

Time frame
Baseline to immediately after the procedure (within the same treatment visit).
3

Anxiety assessment using Venham's clinical anxiety scale

The Venham's clinical anxiety rating scale will be used to assess the child's dental anxiety at baseline, during and after anesthesia injection and extraction procedure. The assessment will take place by the operator and the independent outcome assessor using the recorded video tapes. This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.

Time frame
Baseline to immediately after the procedure (within the same treatment visit).
4

Pain assessment using Wong-Baker FACES pain rating scale

The Wong-Baker FACES Pain Rating Scale will be used to quantify the child's pain experience. This scale ranges from a neutral face, assigned a score of "0," indicating no pain, to a frowning face with a score of "10," representing the highest level of discomfort. The scale will be explained to the child, who will be asked to choose the face that represents how much pain he or she will feel during anesthesia injection and extraction from one of the graphic rating scales by pointing his finger at one of the six faces shown on the chart will be given to him.

Time frame
Baseline to immediately after the procedure (within the same treatment visit).

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara Hazem Mohamed Rabie

Lead sponsor

Alexandria University

Sponsor institution

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