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NCT Number: NCT07717229

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

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.

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Key information

Conditions

Dental Anxiety

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October University for Modern Science and Arts

Giza, 12451, Egypt

Location status: Recruiting

Location contact

Naglaa Ibrahim Ezz Eldin, Professor Doctor

CONTACT

[email protected]

00201001984184

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BrightHearts"biofeedback relaxation tool

Other

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

Primary outcomes

  1. Evaluation of Dental Anxiety.

    Time frame: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection

    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

  1. Evaluation of Dental Anxiety

    Time frame: Baseline (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.

  2. Behavior Assessment

    Time frame: During injection

    FLACC Rating Scale. Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Scores range from 0 to 10, with higher scores indicating greater pain and distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Ahmed Khira, Bachelor Degree

CONTACT

[email protected]

00201012592478

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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