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

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ClinicalTrials.gov Identifier: NCT03772483
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Plovdiv Medical University

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE December 15, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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?"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children
Official Title  ICMJE Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized Intervention Model: Split-mouth assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Injection Pain
  • Local Anesthesia
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Active Comparator: Control group
    Local anesthesia with conventional syringe
    Intervention: Procedure: Local anesthesia with conventional syringe
  • Active Comparator: Virtual reality group
    Local anesthesia with conventional syringe + VR device
    Intervention: Device: Local anesthesia with conventional syringe + VR device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elitsa Veneva, DMD +359898424151 elitza.veneva@gmail.com
Contact: Ani Belcheva, PhD abelcheva@gmail.com
Listed Location Countries  ICMJE Bulgaria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772483
Other Study ID Numbers  ICMJE PlovdivMU2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Plovdiv Medical University
Study Sponsor  ICMJE Plovdiv Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elitsa Veneva, DMD Plovdiv Medical University
PRS Account Plovdiv Medical University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP