Dental AnxietyARNCT06954883
Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures
A study testing Augmented Reality Distraction in people with Dental Anxiety, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Augmented Reality Distraction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-10 years
- Indicated for anterior primary tooth extraction
- No previous exposure to local anesthesia
Who cannot join
- Medically compromised children
- Children with cognitive or communication impairments
- Children who underwent similar treatment within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Augmented Reality Distraction, Standard Care (Tell-Show-Do Technique)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality DistractionBehavioural
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.
Standard Care (Tell-Show-Do Technique)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AR Distraction | Experimental | Participants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction. Receives: Behavioral: Augmented Reality Distraction |
| Tell-Show-Do | Active comparator | Participants undergo standard Tell-Show-Do behavior guidance during treatment. Receives: Behavioral: Standard Care (Tell-Show-Do Technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the dental extraction procedure.
Secondary outcomes (2)
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)
Measured: 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.
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 May 2025
- Primary completion30 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed kamel Abdel Naser soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954883
- Sponsor's protocol ID
- 17-2024-0004
- Acronym
- AR
- Status last verified
- Dec 2025
- First submitted
- 8 Apr 2025
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06954883
- Acronym / sponsor ID
- AR / 17-2024-0004
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| AR Distraction | Experimental | Behavioral: Augmented Reality DistractionParticipants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction. |
| Tell-Show-Do | Active comparator | Behavioral: Standard Care (Tell-Show-Do Technique)Participants undergo standard Tell-Show-Do behavior guidance during treatment. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-10 years
- Indicated for anterior primary tooth extraction
- No previous exposure to local anesthesia
Key exclusion criteria (3 listed)
- Medically compromised children
- Children with cognitive or communication impairments
- Children who underwent similar treatment within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality DistractionParticipants 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. | Behavioural | AR Distraction |
| 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. | Behavioural | Tell-Show-Do |
Primary outcome
Pain Score Using Wong-Baker FACES Scale
Time frame: 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.
2 secondary outcomes
1. Children's Fear Survey Schedule-Dental Subscale
Time frame: Immediately after the dental extraction procedure.
Heart Rate as Physiological Indicator of Anxiety
Time frame: Immediately post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Distraction in people with Dental Anxiety, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Using Wong-Baker FACES Scale (time frame: Immediately after the dental extraction procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.