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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR Distraction | Experimental | Participants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction. |
|
| Tell-Show-Do | Active Comparator | Participants undergo standard Tell-Show-Do behavior guidance during treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Indicated for anterior primary tooth extraction
No previous exposure to local anesthesia
Exclusion Criteria:
Children with cognitive or communication impairments
Children who underwent similar treatment within the past 3 months
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | Asyut Governorate | 71511 | Egypt |
Number of Participants Screened: 60 eligible participants were enrolled after screening
Reasons for Exclusions:
Number Assigned to Arms:
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:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants (N=60; AR group n=30, Control group n=30) were included in baseline analyses. No participants were excluded after randomization, and baseline data were complete for all individuals.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at the time of enrollment, measured as the difference between the participant's date of birth and the date of study enrollment. Reported as mean ± standard deviation (SD) in years Units: Years (mean and SD) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Aug 2025 | Mean | Standard Deviation | Score on a scale | Immediately after the dental extraction procedure. |
|
From the start of the dental extraction procedure until 1 hour post-procedure."
Adverse events were defined broadly as any undesirable experience reported by the child or observed by the dental team during or after the extraction procedure. The focus was on minor, short-term reactions potentially related to the AR headset (e.g., dizziness, headache, eye strain) or the dental extraction (e.g., mild bleeding, transient discomfort). Events were recorded only if they occurred during the dental visit or within 1 hour post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AR Distraction | Participants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction. |
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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."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Kamel Abdel Naser | Assuit university | 01061553007 | a.k.soliman@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2025 | Aug 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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
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Both participants and outcome assessors/data analysts don't know group assignment.
|
| 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. |
|
| Immediately after the dental extraction procedure. |
| 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. | Immediately post-procedure |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Biological sex of participants as reported by the parent or legal guardian at enrollment. Categorized as male or female and reported as number and percentage of participants in each arm. Units: Number (%) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| CFSS-DS | Dental anxiety was assessed before the 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) | Mean | Standard Deviation | score on a scale |
|
| Heart Rate | 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 before the 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. | Mean | Standard Deviation | beats per minute |
|
| OG001 | 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. |
|
|
| 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) | 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. | Posted | Aug 2025 | Mean | Standard Deviation | score on a scale | Immediately after the dental extraction procedure. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Immediately post-procedure |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Tell-Show-Do | Participants undergo standard Tell-Show-Do behavior guidance during treatment. | 0 | 30 | 0 | 30 | 0 | 30 |
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