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

• ClinicalTrials.gov Identifier: NCT03772483
• Recruitment Status: Completed
• First Posted: December 11, 2018
• Last Update Posted: June 4, 2021
• Sponsor: Plovdiv Medical University
• Information provided by (Responsible Party): Plovdiv Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Injection Pain; Local Anesthesia	Procedure: Local anesthesia with conventional syringe; Device: Local anesthesia with conventional syringe + VR device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized Intervention Model: Split-mouth assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
• Actual Study Start Date: December 15, 2018
• Actual Primary Completion Date: June 10, 2019
• Actual Study Completion Date: October 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control group; Local anesthesia with conventional syringe	Procedure: 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
Active Comparator: Virtual reality group; Local anesthesia with conventional syringe + VR device	Device: 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

Outcome Measures

Primary Outcome Measures :

1. Pain felt during injection using visual analogue scale [ Time Frame: Immediately after local anesthetic delivery ]
   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.

Secondary Outcome Measures :

1. Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale [ Time Frame: During local anesthesia procedure ]
   Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
2. Self-reported anxiety during injection evaluated on FIS [ Time Frame: Immediately after local anesthetic delivery ]
   The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).
3. Heart rate dynamics of the patient [ Time Frame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment. ]
   Patient's left index finger is connected to a portable recording pulse oximeter for children.
4. Assessment of self-reported dental fear on CFSS-DS questionnaire [ Time Frame: At least 5 minutes before local anesthesia ]
   Assessment will be performed prior to both visits.
5. Patient preference to local anesthesia method [ Time Frame: One week after second procedure ]
   One week after the second dental visit, the patient is reached by a phone call and asked: "Which method do you prefer to put your tooth to sleep? With the virtual reality device or without it?"

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Bulgaria

Department of Pediatric Dentistry, Faculty of Dental Medicine

Plovdiv, Bulgaria, 4000

Sponsors and Collaborators

Plovdiv Medical University

Investigators

• Principal Investigator: Elitsa Veneva, DMD; Plovdiv Medical University

More Information

• Responsible Party: Plovdiv Medical University
• ClinicalTrials.gov Identifier: NCT03772483
• Other Study ID Numbers: PlovdivMU2
• First Posted: December 11, 2018
• Last Update Posted: June 4, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Plovdiv Medical University:

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

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs