Trial Outcomes & Findings for Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures (NCT NCT06954883)
NCT ID: NCT06954883
Last Updated: 2026-01-06
Results Overview
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.
COMPLETED
NA
60 participants
Immediately after the dental extraction procedure.
2026-01-06
Participant Flow
Recruitment Status: Completed Actual Enrollment: 60 participants Start Date: May 15 2025 Primary Completion Date: July 30 2025 Study Completion Date: August 15 2025 Recruitment Locations: • Faculty of Dentistry, Assuit University, Egypt Eligibility Criteria: * Ages: 6-10 years * Sex: All * Accepts Healthy Volunteers: Yes * Inclusion Criteria: * Children requiring primary anterior tooth extractions * No prior experience of local anesthesia * Exclusion Criteria: * Previous local anesthesia
Number of Participants Screened: 60 eligible participants were enrolled after screening Reasons for Exclusions: * previous anesthesia experience, special needs, anxiety disorder diagnosis, recent root planing) * Declined to participate Number Assigned to Arms: * AR Group: 30 participants * Control Group: 30 participants
Participant milestones
| Measure |
AR-based Distraction
Children aged 6-10 years (both sexes, Egyptian ethnicity) received augmented reality (AR) distraction during primary anterior tooth extraction under local infiltration anesthesia. Each child selected a cartoon video displayed through a head-mounted AR/VR device (IGY 360 headset connected to a smartphone). The device projected AR animations (e.g., 3D celestial bodies) into the child's view, diverting attention throughout topical anesthesia, injection, and extraction.
|
Standard Care (Tell-Show-Do Technique)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AR-based Distraction
n=30 Participants
Children aged 6-10 years (both sexes, Egyptian ethnicity) received augmented reality (AR) distraction during primary anterior tooth extraction under local infiltration anesthesia. Each child selected a cartoon video displayed through a head-mounted AR/VR device (IGY 360 headset connected to a smartphone). The device projected AR animations (e.g., 3D celestial bodies) into the child's view, diverting attention throughout topical anesthesia andinjection.
|
Total
n=60 Participants
Total of all reporting groups
|
Standard Care (Tell-Show-Do Technique)
n=30 Participants
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.
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|---|---|---|---|
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Age, Continuous
|
7.8 Years
STANDARD_DEVIATION 1.2 • n=30 Participants
|
7.85 Years
STANDARD_DEVIATION 1.14 • n=60 Participants
|
7.9 Years
STANDARD_DEVIATION 1.1 • n=30 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=30 Participants
|
29 Participants
n=60 Participants
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
31 Participants
n=60 Participants
|
15 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
CFSS-DS
|
29.7 score on a scale
STANDARD_DEVIATION 4.8 • n=30 Participants
|
29.9 score on a scale
STANDARD_DEVIATION 4.97 • n=60 Participants
|
30.1 score on a scale
STANDARD_DEVIATION 5.2 • n=30 Participants
|
|
Heart Rate
|
95 beats per minute
STANDARD_DEVIATION 10 • n=30 Participants
|
94.5 beats per minute
STANDARD_DEVIATION 10.43 • n=60 Participants
|
94 beats per minute
STANDARD_DEVIATION 11 • n=30 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AR-based Distraction
n=30 Participants
Children aged 6-10 years (both sexes, Egyptian ethnicity) received augmented reality (AR) distraction during primary anterior tooth extraction under local infiltration anesthesia. Each child selected a cartoon video displayed through a head-mounted AR/VR device (IGY 360 headset connected to a smartphone). The device projected AR animations (e.g., 3D celestial bodies) into the child's view, diverting attention throughout topical anesthesia, injection, and extraction.
|
Standard Care (Tell-Show-Do Technique)
n=30 Participants
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.
|
|---|---|---|
|
Pain Score Using Wong-Baker FACES Scale
|
2.3 Score on a scale
Standard Deviation 1.2
|
4.5 Score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Immediately after the dental extraction procedure.Population: The analysis population consisted of all enrolled and randomized children who completed the CFSS-DS questionnaire immediately after the dental extraction procedure (N = 60; AR-based Distraction n = 30, Standard Care n = 30). No exclusions occurred and complete data were available for all participants.
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)
Outcome measures
| Measure |
AR-based Distraction
n=30 Participants
Children aged 6-10 years (both sexes, Egyptian ethnicity) received augmented reality (AR) distraction during primary anterior tooth extraction under local infiltration anesthesia. Each child selected a cartoon video displayed through a head-mounted AR/VR device (IGY 360 headset connected to a smartphone). The device projected AR animations (e.g., 3D celestial bodies) into the child's view, diverting attention throughout topical anesthesia, injection, and extraction.
|
Standard Care (Tell-Show-Do Technique)
n=30 Participants
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.
|
|---|---|---|
|
1. Children's Fear Survey Schedule-Dental Subscale
|
17.6 score on a scale
Standard Deviation 3.9
|
26.8 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Immediately post-procedurePopulation: All randomized participants were included in the analysis of heart rate (N = 60; AR-based Distraction n = 30, Standard Care n = 30). No participants were excluded and no data were missing.
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.
Outcome measures
| Measure |
AR-based Distraction
n=30 Participants
Children aged 6-10 years (both sexes, Egyptian ethnicity) received augmented reality (AR) distraction during primary anterior tooth extraction under local infiltration anesthesia. Each child selected a cartoon video displayed through a head-mounted AR/VR device (IGY 360 headset connected to a smartphone). The device projected AR animations (e.g., 3D celestial bodies) into the child's view, diverting attention throughout topical anesthesia, injection, and extraction.
|
Standard Care (Tell-Show-Do Technique)
n=30 Participants
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.
|
|---|---|---|
|
Heart Rate as Physiological Indicator of Anxiety
|
80 beats per minute (bpm)
Standard Deviation 8
|
89 beats per minute (bpm)
Standard Deviation 10
|
Adverse Events
AR Distraction
Tell-Show-Do
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place