Virtual Reality Distraction in Pediatric Patients.

NCT ID: NCT06355492

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-07-31

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 .

Conditions

Virtual Reality; Distraction; Infiltration Anesthesia; Pediatric Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients will take buccal infiltration anesthesia using (regular screen).

Group Type: PLACEBO_COMPARATOR

regular screen

Intervention Type: DEVICE

Patients will take buccal infiltration anaethesia using (regular screen ).

VR group

Patients will take buccal infiltration anesthesia using (Virtual reality goggles).

Group Type: EXPERIMENTAL

Virtual reality goggles (VR )

Intervention Type: DEVICE

Patients will take buccal infiltration anaethesia using (Virtual reality goggles) that properly adjusted around the patient's head and in front of his/her eyes.

Interventions

Virtual reality goggles (VR )

Patients will take buccal infiltration anaethesia using (Virtual reality goggles) that properly adjusted around the patient's head and in front of his/her eyes.

Intervention Type: DEVICE

regular screen

Patients will take buccal infiltration anaethesia using (regular screen ).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rokia Abdelrhman Saad Elfaramawy

Pediatric Dentistry, Oral Health and Preventive Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rokia Abdelrhman Saad Elfaramawy

Tanta, El-Gharbia, Egypt

Countries

Egypt

Facility Contacts

Rokia A Elfaramawy, BDS

Role: primary

Rokiaabdelrahman94@gmail.com

01069823221

References

Kamath PS. A novel distraction technique for pain management during local anesthesia administration in pediatric patients. J Clin Pediatr Dent. 2013 Fall;38(1):45-7. doi: 10.17796/jcpd.38.1.265807t236570hx7.

Reference Type: BACKGROUND

PMID: 24579282 (View on PubMed)

Custodio NB, Costa FDS, Cademartori MG, da Costa VPP, Goettems ML. Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. Pediatr Dent. 2020 Mar 15;42(2):93-102.

Reference Type: BACKGROUND

PMID: 32276674 (View on PubMed)

Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

Reference Type: BACKGROUND

PMID: 27409593 (View on PubMed)

Other Identifiers

2090/10/30

Identifier Type: -

Identifier Source: org_study_id