Comparison Between the Analgesic Effectiveness of Virtual Reality and Topical Anesthesia: A Clinical Study

NCT04919421 | Completed DMC

• 1 other identifier: RiyadhEU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A split-mouth, controlled trial aimed to clinically compare and evaluate the effectiveness of virtual reality versus topical anesthesia gel prior to administration of dental anesthesia injection in reducing the perceived pain and anxiety level in adult patients and to find out their preferred procedure. Heart rate before and after the end of the procedure will be identified, pain intensity of the injection will be identified using a scale, and finally patients' preference will be identified using a questionnaire.

Conditions

Pain

Keywords

pain perception; virtual reality

Outcome Measures

Primary Outcomes (3)

• Heart rate

  heart rate will be measured for the participants using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter)

  immediately after the intervention/procedure (injection)

• Wong-Baker faces pain rating scale (WBFPS)

  A tool to measure the intensity of pain comprising a scale from 0 to 10. The patient will select a number based on the intensity of the pain, "0" means no pain, "10" means extremely severe pain.

  3 minutes after the intervention/procedure (injection)

• Participant's future preference

  Each participant will be asked by a questionnaire to state his/her preference for the delivery system of future injections

  5 minutes after the intervention/procedure (injection)

Study Arms (2)

Virtual reality

ACTIVE COMPARATOR

Participants will wear a virtual reality headset during the dental injection in which a video is playing.

Device: Dental injection and virtual reality device

Topical gel

ACTIVE COMPARATOR

Participants will receive application of topical anesthetic gel on the site of dental injection.

Drug: Dental injection and topical gel application

Interventions

Dental injection and topical gel application DRUG

Topical anesthesia gel will be applied followed by dental injection with 1.8 ml Xylocaine 20mg/ml (DENSPLY Pharmaceutical); adrenaline: 1 : 100.000, delivered in cartridges using a 27 -gauge short needle (0.4 x 25 mm,C-K jet) and sterile non-aspirating syringe.

Also known as: No other name

Topical gel

Dental injection and virtual reality device DEVICE

Dental injection will be made while the participants are wearing virtual reality device.

Also known as: No other name

Virtual reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I, aged between 18 and 65, both male and female, who required bilateral local anesthetic injections in the premolar teeth in the upper jaw.
• Participants are in good general health, take no medications, and have no contraindications to the use of local anesthetic.
• The ability to understand oral and written instructions, and the ability to use the VR controller.

You may not qualify if:

• Patients who need intravenous sedation cannot participate in the study.
• If a patient requires only single visit/ treatment or if he/she cannot attend the other visit.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Pain

Interventions

Dental Health Services

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ammar AbuMostafa, BDS, MSC

  Riyadh Elm University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: June 9, 2021
• Study Start: November 10, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

SA (1)