Effectiveness of BrightHearts Biofeedback Relaxation and Virtual Reality Distraction During Inferior Alveolar Nerve Block Injection in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorOctober University for Modern Sciences and Arts

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • BrightHearts"biofeedback relaxation tool

    Other intervention

    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 distraction

    Device

    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 technique

    Behavioral

    The Verbal distraction method technique involves: patient is given an instruction to do in order to divert his/her attention

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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

Other outcomes

Sponsors and contacts

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