About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Children with special health care needs
Children or parents who are unable or unwilling to cooperate with the study protocol or assessment
Trial design
Parallel
Treatments tested in this trial
BrightHearts"biofeedback relaxation tool
Other interventionBefore 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 distraction
Deviceparticipants 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 technique
BehavioralThe Verbal distraction method technique involves: patient is given an instruction to do in order to divert his/her attention
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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