Dental AnxietyNCT07717229
Effectiveness of BrightHearts Biofeedback Relaxation and Virtual Reality Distraction During Inferior Alveolar Nerve Block Injection in Children
A study testing BrightHearts"biofeedback relaxation tool, Virtual Reality distraction and Verbal distraction technique in people with Dental Anxiety, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
The study is designed to compare the effectiveness of "BrightHearts" biofeedback relaxation tool versus Virtual Reality distraction and Verbal distraction as a distraction methods in reducing dental anxiety and improving behavior during the inferior alveolar nerve block procedure. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- BrightHearts"biofeedback relaxation tool, Virtual Reality distraction and Verbal distraction technique
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 7 to 12 years
- Children who have dental procedures that require an inferior alveolar nerve block injection.
- Healthy Children.
- Children who fall under Frankl's behavioral rating of 2 (negative) or 3 (positive)
Who cannot join
- Children with special health care needs
- Children or parents who are unable or unwilling to cooperate with the study protocol or assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October University for Modern Science and Arts
Giza, 12451
Naglaa Ibrahim Ezz Eldin, Professor Doctor, 00201001984184, niezz@msa.edu.eg
About this study
Official title: A Comparative Evaluation of the Effectiveness of the BrightHearts Application as a Biofeedback Relaxation Tool Versus Virtual Reality Distraction in Reducing Dental Anxiety and Improving Behavior in Children During Inferior Alveolar Nerve Block Injection: A Randomized Controlled Trial
The study is designed to compare the effectiveness of "BrightHearts" biofeedback relaxation tool versus Virtual Reality distraction and Verbal distraction as a distraction methods in reducing dental anxiety and improving behavior during the inferior alveolar nerve block procedure.
- Conditions
- Dental Anxiety
- Being tested
- BrightHearts"biofeedback relaxation tool, Virtual Reality distraction, Verbal distraction technique
- Keywords
- dental anxiety, inferior alveolar nerve block, brighthearts, virtual reality, biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightHearts"biofeedback relaxation toolOther
Before the inferior alveolar nerve block procedure, Participants will be taught to use the application after given instructions.
They will be asked to keep a constant color by focusing on breathing slowly, then they will be allowed to use the application a few minutes before the inferior alveolar nerve block procedure
Virtual Reality distractionDevice
participants in this group will experience Virtual Reality distraction eyewear. After giving an introduction about it, they will be allowed to accommodate, then they will be wearing it during the inferior alveolar nerve block procedure in an environment designed to distract them during the injection. The Virtual Reality distraction content will be age-appropriate and engaging, and feature interactive (e.g., Fun animations, and Cartoons).
Verbal distraction techniqueBehavioural
The Verbal distraction method technique involves:
patient is given an instruction to do in order to divert his/her attention
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: BrightHearts"biofeedback relaxation tool |
| Group B | Active comparator | Not described Receives: Device: Virtual Reality distraction |
| Group C | Active comparator | Not described Receives: Behavioral: Verbal distraction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Dental Anxiety.
Using Heart rate monitor. Heart Rate (beats per minute [bpm]) measured using a heart rate monitor. Higher heart rate values indicate greater physiological anxiety.
Measured: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection
Secondary outcomes (2)
Evaluation of Dental Anxiety
Using Facial Image Scale scores range from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating highest anxiety (very unhappy face). Higher scores indicate greater dental anxiety.
Measured: Baseline (5 minutes before injection)and immediately after injection.
Behavior Assessment
FLACC Rating Scale. Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Scores range from 0 to 10, with higher scores indicating greater pain and distress.
Measured: During injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Nov 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Khira, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717229
- Sponsor's protocol ID
- REC-D 22511-5
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Effectiveness of the BrightHearts Application as a Biofeedback Relaxation Tool Versus Virtual Reality Distraction in Reducing Dental Anxiety and Improving Behavior in Children During Inferior Alveolar Nerve Block Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07717229
- Acronym / sponsor ID
- REC-D 22511-5
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, inferior alveolar nerve block, brighthearts, virtual reality, biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to compare the effectiveness of "BrightHearts" biofeedback relaxation tool versus Virtual Reality distraction and Verbal distraction as a distraction methods in reducing dental anxiety and improving behavior during the inferior alveolar nerve block procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: BrightHearts"biofeedback relaxation tool |
| Group B | Active comparator | Device: Virtual Reality distraction |
| Group C | Active comparator | Behavioral: Verbal distraction technique |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 7 to 12 years
- Children who have dental procedures that require an inferior alveolar nerve block injection.
- Healthy Children.
- Children who fall under Frankl's behavioral rating of 2 (negative) or 3 (positive)
Key exclusion criteria (2 listed)
- Children with special health care needs
- Children or parents who are unable or unwilling to cooperate with the study protocol or assessment
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 |
|---|---|---|
| BrightHearts"biofeedback relaxation toolBefore the inferior alveolar nerve block procedure, Participants will be taught to use the application after given instructions. They will be asked to keep a constant color by focusing on breathing slowly, then they will be allowed to use the application a few minutes before the inferior alveolar nerve block procedure | Other | Group A |
| Virtual Reality distractionparticipants in this group will experience Virtual Reality distraction eyewear. After giving an introduction about it, they will be allowed to accommodate, then they will be wearing it during the inferior alveolar nerve block procedure in an environment designed to distract them during the injection. The Virtual Reality distraction content will be age-appropriate and engaging, and feature interactive (e.g., Fun animations, and Cartoons). | Device | Group B |
| Verbal distraction techniqueThe Verbal distraction method technique involves: patient is given an instruction to do in order to divert his/her attention | Behavioural | Group C |
Primary outcome
Evaluation of Dental Anxiety.
Time frame: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection
Using Heart rate monitor. Heart Rate (beats per minute [bpm]) measured using a heart rate monitor. Higher heart rate values indicate greater physiological anxiety.
2 secondary outcomes
Evaluation of Dental Anxiety
Time frame: Baseline (5 minutes before injection)and immediately after injection.
Behavior Assessment
Time frame: During injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrightHearts"biofeedback relaxation tool, Virtual Reality distraction and Verbal distraction technique in people with Dental Anxiety, run by October University for Modern Sciences and Arts 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Ahmed Khira, Bachelor Degree (00201012592478, sara.ahmed28@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Dental Anxiety. (time frame: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection). 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 21 Jul 2026.