Virtual Reality Distraction in Pediatric Patients.

Phase 4

Not yet recruiting

• Conditions: Distraction; Infiltration Anesthesia; Pediatric Patients; Virtual Reality
• Interventions: Device: Virtual reality goggles (VR ); Device: regular screen

• Registration Number: NCT06355492
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.

Detailed Description

Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.

A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.

Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.

Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.

Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.

Distraction using VR provided favorable outcomes for adult and pediatric patients during various dental procedures, ranging from simple anesthesia to periodontal, restorative, and pulpal therapy .

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Start: 2024-06-01
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Healthy children with no systemic illness.
2. Cooperative child with frankels behavior rating scale positive or definitely positive.
3. Patient requiring infiltration LA for dental treatment.
4. Children with proper parental consent.
5. Patients who needed non-urgent dental treatment.

Exclusion Criteria

1. Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
2. Children below 5 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VR group	Virtual reality goggles (VR )	Patients will take buccal infiltration anesthesia using (Virtual reality goggles).
Control group	regular screen	Patients will take buccal infiltration anesthesia using (regular screen).

Primary Outcome Measures

Name	Time	Method
Assessment of pain during virtual reality distraction	After 2 weeks from the first visit.	During local anesthesia administration, the face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale (objective scale) will be recorded to assess pain. Immediately after anesthetic administration, the patients will be placed in upright position and will be shown Wong-Baker faces pain rating scale (subjective scale) and give a brief explanation to the child about each face and instruct the child to choose the face that describe their feeling during administration of local anaethesia

Trial Locations

Locations (1)

Rokia Abdelrhman Saad Elfaramawy; 🇪🇬 Tanta, El-Gharbia, Egypt