Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children

NCT ID: NCT03772483

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2019-10-15

Brief Summary

The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS or CS+VR.

Detailed Description

Achieving local anesthesia in children is one of the critical aspects of pain management.

A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.

The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The device used in this study is Noon VR, FXGear, compatible with a mobile phone.

The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where as the virtual reality distraction is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - traditional infiltration or virtual reality device-assisted injection.

Conditions

Injection Pain; Local Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Local anesthesia with conventional syringe

Group Type: ACTIVE_COMPARATOR

Local anesthesia with conventional syringe

Intervention Type: PROCEDURE

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

Virtual reality group

Local anesthesia with conventional syringe + VR device

Group Type: ACTIVE_COMPARATOR

Local anesthesia with conventional syringe + VR device

Intervention Type: DEVICE

Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

Interventions

Local anesthesia with conventional syringe

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

Intervention Type: PROCEDURE

Local anesthesia with conventional syringe + VR device

Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
• Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
• Children without previous experience with local anesthesia for dental treatment.
• Obtained informed consent from parents or gave-givers to participate in the study.

Exclusion Criteria

• Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
• Vision requiring correction with eyeglasses.
• Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
• Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
• Patients with allergy to local anesthetics of the amide group.
• Children, who are first time ever dental patients.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Plovdiv Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elitsa Veneva, DMD

Role: PRINCIPAL_INVESTIGATOR

Plovdiv Medical University

Locations

Department of Pediatric Dentistry, Faculty of Dental Medicine

Plovdiv, , Bulgaria

Countries

Bulgaria

Other Identifiers

PlovdivMU2

Identifier Type: -

Identifier Source: org_study_id