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

Local Anesthesia Clinical Trial

Official title:

Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772483
• Other study ID #: PlovdivMU2
• Status: Completed
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: June 2021
• Source: Plovdiv Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 15, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injection Pain
• Local Anesthesia

Intervention

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

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

Locations

Country	Name	City	State
Bulgaria	Department of Pediatric Dentistry, Faculty of Dental Medicine	Plovdiv

Sponsors (1)

Lead Sponsor	Collaborator
Plovdiv Medical University

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale	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.	During local anesthesia procedure
Secondary	Self-reported anxiety during injection evaluated on FIS	The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).	Immediately after local anesthetic delivery
Secondary	Heart rate dynamics of the patient	Patient's left index finger is connected to a portable recording pulse oximeter for children.	Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Secondary	Assessment of self-reported dental fear on CFSS-DS questionnaire	Assessment will be performed prior to both visits.	At least 5 minutes before local anesthesia
Secondary	Patient preference to local anesthesia method	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?"	One week after second procedure