Virtual Reality Distraction in Pediatric Patients.

NCT06355492 | Not Yet Recruiting Phase 4

• 1 other identifier: 2090/10/30
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Distraction; Infiltration Anesthesia; Pediatric Patients

Outcome Measures

Primary Outcomes (1)

• Assessment of pain during virtual reality distraction

  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

  After 2 weeks from the first visit.

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Device: regular screen

VR group

EXPERIMENTAL

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

Device: Virtual reality goggles (VR )

Interventions

Virtual reality goggles (VR ) 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.

VR group

regular screen DEVICE

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

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Rokia Abdelrhman Saad Elfaramawy

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (3)

• 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.

  PMID: 24579282 BACKGROUND

• 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.

  PMID: 32276674 BACKGROUND

• 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.

  PMID: 27409593 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentistry, Oral Health and Preventive Dentistry Department

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 9, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

EG (1)