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

NCT03772483 | Completed DMC

• 1 other identifier: PlovdivMU2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Pain; Local Anesthesia

Keywords

virtual reality; pain control; pediatric dental patients; pediatric pain management; local anesthesia children

Outcome Measures

Primary Outcomes (1)

• Pain felt during injection using visual analogue scale

  Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.

  Immediately after local anesthetic delivery

Secondary Outcomes (5)

• Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale

  During local anesthesia procedure

• Self-reported anxiety during injection evaluated on FIS

  Immediately after local anesthetic delivery

• Heart rate dynamics of the patient

  Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.

• Assessment of self-reported dental fear on CFSS-DS questionnaire

  At least 5 minutes before local anesthesia

• Patient preference to local anesthesia method

  One week after second procedure

Study Arms (2)

Control group

ACTIVE COMPARATOR

Local anesthesia with conventional syringe

Procedure: Local anesthesia with conventional syringe

Virtual reality group

ACTIVE COMPARATOR

Local anesthesia with conventional syringe + VR device

Device: Local anesthesia with conventional syringe + VR device

Interventions

Local anesthesia with conventional syringe 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

Control group

Local anesthesia with conventional syringe + VR device 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

Virtual reality group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dental Medicine

Plovdiv, 4000, Bulgaria

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Elitsa Veneva, DMD

  Plovdiv Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Intervention Model: Split-mouth assignment

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 11, 2018
• Study Start: December 15, 2018
• Primary Completion: June 10, 2019
• Study Completion: October 15, 2019
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)