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

NCT07717229 | Recruiting DMC

• 1 other identifier: REC-D 22511-5
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Keywords

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

Outcome Measures

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.

  - Baseline (5 minutes before injection) - During injection - 2 minutes after injection

Secondary Outcomes (2)

• Evaluation of Dental Anxiety

  Baseline (5 minutes before injection)and immediately after injection.

• Behavior Assessment

  During injection

Study Arms (3)

Group A

EXPERIMENTAL

Other: BrightHearts"biofeedback relaxation tool

Group B

ACTIVE COMPARATOR

Device: Virtual Reality distraction

Group C

ACTIVE COMPARATOR

Behavioral: Verbal distraction technique

Interventions

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

Group A

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).

Group B

Verbal distraction technique BEHAVIORAL

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

Group C

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Children with special health care needs
• Children or parents who are unable or unwilling to cooperate with the study protocol or assessment

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

October University for Modern Science and Arts

Giza, 12451, Egypt

RECRUITING

Central Study Contacts

Sara Ahmed Khira, Bachelor Degree

CONTACT

00201012592478; sara.ahmed28@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: July 21, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 21, 2026

Record last verified: 2025-11

Locations

EG (1)