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Completed

NCT Number: NCT06954883

Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures

This randomized controlled trial evaluates the effectiveness of augmented reality (AR) as a distraction technique to reduce procedural pain and anxiety in children aged 6-10 undergoing primary tooth extraction. Participants will be randomly assigned to receive either AR distraction via VR goggles or standard tell-show-do behavior management during local anesthesia administration and extraction.

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Key information

Conditions

Dental Anxiety

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

About this study

Pain and anxiety are major challenges in pediatric dental care. AR presents an innovative, non-pharmacological technique to manage procedural distress. The study compares AR distraction versus conventional behavioral guidance in terms of self-reported pain (Wong-Baker FACES), dental anxiety (CFSS-DS), and physiological anxiety (heart rate monitoring). A double-blind design will ensure unbiased outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 6-10 years

Indicated for anterior primary tooth extraction

No previous exposure to local anesthesia

Exclusion criteria

  • Medically compromised children

Children with cognitive or communication impairments

Children who underwent similar treatment within the past 3 months

Treatment and study plan

Augmented Reality Distraction

Behavioral

Participants in this group wore augmented reality (AR) goggles during local anesthesia administration and dental extraction. The AR system displayed interactive 3D animated videos (celestial bodies) to divert attention and reduce procedural pain and anxiety.

Standard Care (Tell-Show-Do Technique)

Behavioral

Children aged 6-10 years (both sexes, Egyptian ethnicity) received behavioral management using the Tell-Show-Do (TSD) technique during primary anterior tooth extraction under local infiltration anesthesia. The clinician explained the procedure in child-friendly language (Tell), demonstrated instruments in a non-threatening manner (Show), and then performed the extraction (Do) without augmented reality or audiovisual distraction.

Primary outcomes

  1. Pain Score Using Wong-Baker FACES Scale

    Time frame: Immediately after the dental extraction procedure.

    Pain was assessed immediately after local anesthesia injection using the Wong-Baker FACES Pain Rating Scale. This validated pediatric pain scale consists of six facial expressions ranging from 0 ("No pain") to 10 ("Worst pain"). Children were asked to select the face that best represented their pain experience, which was then converted into a numeric score. Values are reported as mean ± standard deviation (SD)and were compared between study arms.

Secondary outcomes

  1. 1. Children's Fear Survey Schedule-Dental Subscale

    Time frame: Immediately after the dental extraction procedure.

    Dental anxiety was assessed immediately post-procedure using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS is a validated 15-item questionnaire scored on a 5-point Likert scale (1 = not afraid to 5 = very afraid; total range 15-75, higher scores = greater anxiety). Values were compared between study arms (Augmented Reality distraction vs. Standard Care)

  2. Heart Rate as Physiological Indicator of Anxiety

    Time frame: Immediately post-procedure

    Heart rate was measured in beats per minute (bpm) using a finger pulse oximeter (CMS 50DL, China). Measurements were taken while the child was seated in the dental chair immediately post-procedure as a physiological indicator of anxiety. Values are reported as mean ± standard deviation (SD). The outcome was defined as the post-procedure heart rate value, compared between study arms.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effectiveness of Augmented Reality as a Distraction Technique for Reducing Pain and Anxiety in Pediatric Dental Extractions: A Parallel-Group, Double-Blind Randomized Controlled Trial

Acronym: AR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Jan 6, 2026

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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