Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures

NCT06954883 | Completed Results

• 1 other identifier: 17-2024-0004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Score Using Wong-Baker FACES Scale

  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.

  Immediately after the dental extraction procedure.

Secondary Outcomes (2)

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

  Immediately after the dental extraction procedure.

• Heart Rate as Physiological Indicator of Anxiety

  Immediately post-procedure

Study Arms (2)

AR Distraction

EXPERIMENTAL

Participants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction.

Behavioral: Augmented Reality Distraction

Tell-Show-Do

ACTIVE COMPARATOR

Participants undergo standard Tell-Show-Do behavior guidance during treatment.

Behavioral: Standard Care (Tell-Show-Do Technique)

Interventions

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.

Tell-Show-Do

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.

AR Distraction

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-10 years
• Indicated for anterior primary tooth extraction
• No previous exposure to local anesthesia

You may not qualify if:

• Medically compromised children
• Children with cognitive or communication impairments
• Children who underwent similar treatment within the past 3 months

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

This study was limited by its relatively small sample size and single-center setting, which may affect generalizability. Outcomes were assessed only immediately after the procedure, without longer-term follow-up."

Results Point of Contact

• Title: Ahmed Kamel Abdel Naser
• Organization: Assuit university

a.k.soliman@hotmail.com

01061553007

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and outcome assessors/data analysts don't know group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a parallel-group, randomized controlled trial with a 1:1 allocation ratio. Participants were randomized into either the experimental group (augmented reality distraction during dental procedures) or the control group (standard tell-show-do technique). Each participant received only one of the two interventions. No crossover occurred between groups

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 2, 2025
• Study Start: May 15, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 15, 2025
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

EG (1)