Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia

NCT07060170 | Recruiting DMC

• 1 other identifier: FDASU-Rec IM012411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if audio-visual method of distraction is useful to control the pain and fear associated with dental treatment in children. The main questions it aims to answer are:

• How their body reacts-such as changes in heart rate, oxygen levels, and certain chemicals in their saliva-before and after getting local anesthesia? Researchers will test two types of glasses that display cartoons to help children feel less anxious. Participants will:
• Have an introductory visit to be more familiar with dental environment and their cooperation will be tested.
• In the next 2 visits they will wear either of the glasses while receiving local anesthesia
• Saliva will be collected, and their heart rate and oxygen levels will be calculated each time

Conditions

Dental Anxiety; Dental Fear; Dental Fear and Anxiety

Keywords

salivary alpha amylase; dental anxiety; cortisol; Virtual Reality; Local Anesthesia; child; Behavior

Outcome Measures

Primary Outcomes (2)

• Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children

  The Wong-Baker FACES Pain Rating Scale Arabic Version, will be used to subjectively assess the pain perception before and after local anesthetics administration, the scale uses cartoon faces representing pain levels from 0 ("no pain") to 10 ("worst pain imaginable").

  Pain perception will be assessed immediately before, and immediately after local anesthetics administration.

• Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children

  The face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale will be used to objectively assess the pain perception during local anesthetics administration, this scale consists of 5 categories, each category is scored from 0 to 2, with a total score ranging from 0 ("relaxed and comfortable") to 10 ("sever discomfort or pain or both").

  Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.

Secondary Outcomes (4)

• Changes in the levels of the salivary cortisol, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction

  Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.

• Changes in the levels of the salivary alpha amylase, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction

  Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.

• Changes in the heart rate of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction

  Heart rate and oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses

• Changes in the oxygen saturation of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction

  Oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses

Study Arms (2)

Maxillary right primary molars

ACTIVE COMPARATOR

In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the right side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method

Device: Augmented Reality Glasses; Device: Virtual Reality Glasses

Maxillary left primary molars

ACTIVE COMPARATOR

In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the left side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method

Device: Augmented Reality Glasses; Device: Virtual Reality Glasses

Interventions

Augmented Reality Glasses DEVICE

The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia

Maxillary left primary molars; Maxillary right primary molars

Virtual Reality Glasses DEVICE

The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.

Maxillary left primary molars; Maxillary right primary molars

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year-old female and male patients.
• Cooperative patients (rating 3 or 4 on the Frankl's Behavior Rating Scale).
• American Society of Anesthesiologists (ASA) Class (I).
• Patients need dental treatment under local anesthetic infiltration.
• Patients without known anxiety disorders.
• Patients with body weight that is considered normal according to their age and gender (95th percentile growth curve).
• Patients without a prior history of receiving local anesthetic.
• Patients with at least one vital primary molar with deep carious lesion on each side of the dental arch, who require to be treated under local anesthesia

You may not qualify if:

• Patients with special health care needs.
• Patients on corticosteroid medications.
• Patients having known salivary disorders, such as Sjogren's syndrome.
• Parents who refused to sign the informed consent.

Sponsors & Collaborators

• Riham Abbas: lead

Study Sites (1)

Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt

Cairo, Egypt, 11566, Egypt

RECRUITING

Related Publications (5)

• Singh Y, Parameshwarappa P, Mathew MG, Meghana SB, Kenchappa M, Nagaveni NB. Comparison of distraction techniques using salivary biomarkers during local anaesthesia administration in children aged 3-5 years: A clinical study. Indian J Dent Res. 2023 Apr-Jun;34(2):169-173. doi: 10.4103/ijdr.ijdr_132_22.

  PMID: 37787206 BACKGROUND

• Subramaniam SD, Doss B, Chanderasekar LD, Madhavan A, Rosary AM. Scope of physiological and behavioural pain assessment techniques in children - a review. Healthc Technol Lett. 2018 Jul 17;5(4):124-129. doi: 10.1049/htl.2017.0108. eCollection 2018 Aug.

  PMID: 30155264 BACKGROUND

• Sharma Y, Bhatia HP, Sood S, Sharma N, Singh A. Effectiveness of Virtual Reality Glasses Digital Screens and Verbal Command as a Method to Distract Young Patients during Administration of Local Anesthesia. Int J Clin Pediatr Dent. 2021;14(Suppl 2):S143-S147. doi: 10.5005/jp-journals-10005-2094.

  PMID: 35645477 BACKGROUND

• Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.

  PMID: 32440065 BACKGROUND

• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

  PMID: 23277857 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Professor of Pediatric Dentistry and Dental Public Health

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Lecturer of Pediatric Dentistry and Dental Public Health

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Master's Degree Candidate

CONTACT

1554566997; rihamamir@dent.asu.edu.eg

Riham A Abbas, Master's degree Candidate

CONTACT

rihamamir@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The main supervisor will code the patients' tooth allocation in order to blind the statistician and the clinical pathologist who will assess the salivary biomarker levels in the samples.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General practitioner

Model Details: Teeth in each patient will be randomly assigned to receive both interventions sequentially, using a simple randomization technique. Each time a new patient is to be enrolled in the study, he\\she will be asked to select a sequentially numbered sealed opaque envelop that determines which type of distraction method will be implemented first. In the subsequent treatment visit, the other distraction technique will be automatically applied, since this is a split mouth designed study. A set of 40 envelopes (20 envelopes for augmented reality glasses and 20 envelops for virtual reality glasses) will be kept with a third party (the main supervisor), who will not be involved in the data collection, to ensure allocation concealment.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: July 11, 2025
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)