An interventional study of BrightHearts"biofeedback relaxation tool and Virtual Reality distraction in Dental Anxiety, sponsored by October University for Modern Sciences and Arts. Recruiting at 1 site in Egypt. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by October University for Modern Sciences and Arts · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Other: BrightHearts"biofeedback relaxation tool
Device: Virtual Reality distraction
Behavioral: Verbal distraction technique
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
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).
The Verbal distraction method technique involves: patient is given an instruction to do in order to divert his/her attention
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.
Time frame: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection
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.
Time frame: 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.
Time frame: During injection
Plan to share: Undecided
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October University for Modern Sciences and Arts