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NCT Number: NCT07060170

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

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

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Key information

Conditions

Dental Anxiety Anxiety Disorders Behavior Dental Fear Dental Fear and Anxiety Mental Disorders

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt, 11566

Location status: Recruiting

Location contact

Master's Degree Candidate

CONTACT

[email protected]

1554566997 ext. +20

Master's Degree Candidate

PRINCIPAL_INVESTIGATOR

Professor of Pediatric Dentistry and Dental Public Health

CONTACT

[email protected]

1006506028 ext. +20

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 5-8 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Virtual Reality Glasses

Device

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

Primary outcomes

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

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

    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").

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

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

    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").

Secondary outcomes

  1. 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

    Time frame: 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.

    Salivary stress biomarker (salivary cortisol) will be assessed using enzyme linked immunoassay (ELISA) technique.

  2. 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

    Time frame: 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.

    Salivary stress biomarker (salivary alpha amylase) will be assessed using enzyme linked immunoassay (ELISA) technique.

  3. 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

    Time frame: 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

    The physiological measures of heart rate will be used to evaluate the anxiety using pulse oximeter.

  4. 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

    Time frame: 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

    The physiological measures of oxygen saturation will be used to evaluate the anxiety using pulse oximeter.

Study contacts

Contact information is provided by the study sponsor or research team.

Master's Degree Candidate

CONTACT

[email protected]

1554566997 ext. +20

Riham A Abbas, Master's degree Candidate

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Riham Abbas

Other

Registry information

Official study title

The Effect of Augmented Reality Versus Virtual Reality Glasses as Distraction Techniques in Children During the Administration of Local Anesthesia A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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