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
Phase: NA
Conditions: Dental Anxiety
Sponsor: Assiut University

Study Protocol with Statistical Analysis Plan 
Official 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 
NCT Number: NCT06954883 
Unique Protocol ID: 17-2024-0004 
Document Date: April 30, 2025 
Author: Ahmed Kamel Abdel Naser 
Institution: Faculty of Dentistry, Assiut University Dental Hospital 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Administrative Information 
Principal Investigator: Ahmed Kamel Abdel Naser 
Institution: Faculty of Dentistry, Assiut University Dental Hospital 
Trial Registration: ClinicalTrials.gov (NCT06954883) 
Unique Protocol ID: 17-2024-0004 
2. Background and Rationale 
Pediatric dental anxiety and pain are common barriers to care. 
Augmented Reality (AR) may reduce distress by immersive distraction. 
Hypothesis: AR distraction will reduce pain and anxiety vs. Tell–Show–Do. 
3. Objectives 
Primary: To evaluate the effect of AR distraction on pain (Wong-Baker FACES). 
Secondary: To evaluate effect on anxiety (CFSS-DS) and heart rate. 
4. Study Design 
Randomized, controlled, parallel-group, single-blind trial. 
Setting: Pediatric Dentistry Clinic, Assiut University Dental Hospital. 
5. Participants 
Eligibility: Children aged 6–10 years, requiring tooth extraction, ASA I. 
Exclusion: Visual/hearing impairment, neurological disorders, traumatic dental 
history. 
6. Interventions 
AR group: 30 children wore AR headset during anesthesia and extraction. 
Control group: 30 children received Tell–Show–Do technique. 
7. Outcomes 
Primary: Pain (Wong-Baker FACES, 0–10). 
Secondary: Anxiety (CFSS-DS, 15–75), Heart rate (bpm). 

8. Sample Size Calculation 
Based on 2-point difference in Wong-Baker scale, power 80%, alpha=0.05. 
25 per group needed, increased to 30 per group (N=60). 
9. Randomization and Blinding 
Block randomization, sealed envelopes for allocation concealment. 
Outcome assessors blinded to group allocation. 
10. Statistical Analysis Plan 
Analysis: Intention-to-treat. Significance p<0.05, two-sided. 
Continuous data: Mean ± SD, compared with t-tests (independent/paired). 
Effect size (Cohen’s d) calculated. Missing data <5% complete case. 
Secondary outcomes analyzed similarly. Sensitivity analysis: per-protocol. 
11. Ethics and Dissemination 
Approved by Institutional Review Board, informed consent obtained. 
Trial conducted per Declaration of Helsinki. Results to be published.