Clinical trial Recruiting at 1 site Interventional Ages 7 to 12

BrightHearts biofeedback vs virtual reality vs verbal distraction for kids during a dental nerve block

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

Run by October University for Modern Sciences and Arts · NCT07717229 · Data updated 2026-11-12

This study tests whether BrightHearts biofeedback relaxation is as good as or better than virtual reality distraction or verbal distraction for reducing anxiety in children during an inferior alveolar nerve block.

Quick facts

Study typeInterventional
Ages7 Years to 12 Years
SexAll
Enrollment39 (estimated)
SponsorOctober University for Modern Sciences and Arts
Academic / other
Locations1 site (Giza)
StatusRecruiting
StartedNovember 15, 2025
Main results expectedAugust 30, 2026
Study endsSeptember 30, 2026
Registry record updatedJuly 21, 2026
Trial IDNCT07717229 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 7 to 12 who need an inferior alveolar nerve block and have a Frankl rating of 2 or 3.

Probably not a fit

Children with special health care needs or those unable to cooperate may not benefit from the interventions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares three distraction methods used during pediatric dental anesthesia: BrightHearts biofeedback relaxation, virtual reality distraction, and verbal distraction. Participants are children aged 7 to 12 who require an inferior alveolar nerve block and have a Frankl behavior rating of 2 or 3. The aim is to see which method most effectively reduces dental anxiety and improves cooperative behavior during the procedure. Healthy children are eligible, while those with special health care needs or who cannot comply with the protocol are excluded. The study is led by October University for Modern Sciences and Arts in Giza, with no listed collaborators.

Why it matters

Potential benefit: If successful, children could experience lower anxiety and smoother dental visits during injections.

How similar studies have gone: Previous work has explored distraction and relaxation tools for reducing pediatric dental anxiety, but direct head-to-head comparisons in this specific setting are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Children from 7 to 12 years
2. Children who have dental procedures that require an inferior alveolar nerve block injection.
3. Healthy Children.
4. Children who fall under Frankl's behavioral rating of 2 (negative) or 3 (positive)

Exclusion Criteria:

1. Children with special health care needs
2. Children or parents who are unable or unwilling to cooperate with the study protocol or assessment

Where it's running

  • October University for Modern Science and Arts
    Giza, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.