Effectiveness of BrightHearts Biofeedback Relaxation and Virtual Reality Distraction During Inferior Alveolar Nerve Block Injection in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BrightHearts"biofeedback relaxation tool, Virtual Reality distraction, Verbal distraction technique.
- Who it may be relevant to
- Registry conditions: Dental Anxiety. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other BrightHearts"biofeedback relaxation tool
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 - Device Virtual Reality distraction
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). - Behavioral Verbal distraction technique
The Verbal distraction method technique involves: patient is given an instruction to do in order to divert his/her attention
Primary outcome measures
- Evaluation of Dental Anxiety. [Time frame: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection]
Secondary outcome measures (2)
- Evaluation of Dental Anxiety [Time frame: Baseline (5 minutes before injection)and immediately after injection.]
- Behavior Assessment [Time frame: During injection]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Children with special health care needs
- Children or parents who are unable or unwilling to cooperate with the study protocol or assessment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- October University for Modern Science and Arts — Giza
Identifiers
NCT: NCT07717229 · REC-D 22511-5