A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.

November 4, 2021 updated by: Abdulrahman Alasmari, Riyadh Elm University

A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia. A Clinical Experimental Study

The aim of this study is to determine the efficacy of sweet in compare to 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 5 - 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 sweet is allocated to first local anesthesia procedure and VR is allocated to 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+sweet or CS+VR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Achieving local anesthesia in children is one of the critical aspects of pain management and they effect the quality of treatment as well as behavior of child.

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.

While sweet-tasting reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a pre absorptive mechanism related to the sweet taste.

The aim of this study is to determine the efficacy of sweet-testing compare to 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 Harga Miniso Vr Glass 3d terbaru, compatible with a mobile phone.

The sweet used is xylitol tablet The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 5-12 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 is the sweet-test applied with first local anesthesia procedure and the virtual reality distraction is allocated to 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 - sweet test infiltration or virtual reality device-assisted injection.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11681
        • AbdulRahman Alasmari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, xylitol.
  • Children, who are first time ever dental patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sweet test group
Local anesthesia with conventional syringe Procedure: Local anesthesia with conventional syringe + xylitol sublingual tablet 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.
Drug: Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
Other Names:
  • lignocaine
Dietary supplement: Xylitol
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 while xylitol tablet putted under tongue
Other Names:
  • Xylitol candy
Active Comparator: Virtual reality group

Local anesthesia with conventional syringe + VR device Device: Local anesthesia with conventional syringe + VR device Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.

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.
Drug: Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
Other Names:
  • lignocaine
Device: Virtual reality device (Harga Miniso Vr Glass 3d terbaru)

Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.

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

Other Names:
  • VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after local anesthetic delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During local anesthesia procedure
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).
Immediately after local anesthetic delivery
Heart rate dynamics of the patient
Time Frame: Baseline (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.
Baseline (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
Time Frame: At least 5 minutes before local anesthesia
After each procedure
At least 5 minutes before local anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Elm University

Investigators

  • Principal Investigator: AbdulRahman Alasmari, Resident, Riyadh Elm University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/2020/489/269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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