Dental Anxiety
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALAugmented Reality Distraction
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.
BEHAVIORALStandard 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both participants and outcome assessors/data analysts don't know group assignment.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Using Wong-Baker FACES Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| 1. Children's Fear Survey Schedule-Dental Subscale | 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) |
| Heart Rate as Physiological Indicator of Anxiety | 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. |
Countries
Egypt
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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 andinjection. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | AR-based Distraction | Total | Standard Care (Tell-Show-Do Technique) |
|---|---|---|---|
| Age, Continuous | 7.8 Years STANDARD_DEVIATION 1.2 | 7.85 Years STANDARD_DEVIATION 1.14 | 7.9 Years STANDARD_DEVIATION 1.1 |
| CFSS-DS | 29.7 score on a scale STANDARD_DEVIATION 4.8 | 29.9 score on a scale STANDARD_DEVIATION 4.97 | 30.1 score on a scale STANDARD_DEVIATION 5.2 |
| Heart Rate | 95 beats per minute STANDARD_DEVIATION 10 | 94.5 beats per minute STANDARD_DEVIATION 10.43 | 94 beats per minute STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 16 Participants | 31 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Immediately after the dental extraction procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR-based Distraction | Pain Score Using Wong-Baker FACES Scale | 2.3 Score on a scale | Standard Deviation 1.2 |
| Standard Care (Tell-Show-Do Technique) | Pain Score Using Wong-Baker FACES Scale | 4.5 Score on a scale | Standard Deviation 1.3 |
Secondary
1. Children's Fear Survey Schedule-Dental Subscale
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR-based Distraction | 1. Children's Fear Survey Schedule-Dental Subscale | 17.6 score on a scale | Standard Deviation 3.9 |
| Standard Care (Tell-Show-Do Technique) | 1. Children's Fear Survey Schedule-Dental Subscale | 26.8 score on a scale | Standard Deviation 4.5 |
Secondary
Heart Rate as Physiological Indicator of Anxiety
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.
Time frame: Immediately post-procedure
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR-based Distraction | Heart Rate as Physiological Indicator of Anxiety | 80 beats per minute (bpm) | Standard Deviation 8 |
| Standard Care (Tell-Show-Do Technique) | Heart Rate as Physiological Indicator of Anxiety | 89 beats per minute (bpm) | Standard Deviation 10 |