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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717229
Enrollment
39
Registered
2026-07-21
Start date
2025-11-15
Completion date
2026-09-30
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Keywords

dental anxiety, inferior alveolar nerve block, brighthearts, virtual reality, biofeedback

Brief summary

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

OTHERBrightHearts"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

DEVICEVirtual 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).

BEHAVIORALVerbal distraction technique

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

Sponsors

October University for Modern Sciences and Arts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Dental Anxiety.- Baseline (5 minutes before injection) - During injection - 2 minutes after injectionUsing Heart rate monitor. Heart Rate (beats per minute \[bpm\]) measured using a heart rate monitor. Higher heart rate values indicate greater physiological anxiety.

Secondary

MeasureTime frameDescription
Evaluation of Dental AnxietyBaseline (5 minutes before injection)and immediately after injection.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 AssessmentDuring injectionFLACC Rating Scale. Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Scores range from 0 to 10, with higher scores indicating greater pain and distress.

Countries

Egypt

Contacts

CONTACTSara Ahmed Khira, Bachelor Degree
sara.ahmed28@msa.edu.eg00201012592478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026