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

NCT ID: NCT04919421

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2020-01-30

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.

Detailed Description

Steps of the Experiment

Step I: before the administration of the local anesthesia injection, heart rate will be measured for the patients using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.

Step II: at the first appointment, patients will be randomly allocated to receive the injection of the local anesthesia either with topical anesthetic gel or with virtual reality in one side of the jaw.

Step III: immediately after dental anesthesia injection procedure, the patient will be asked to rate the level of perceived pain, using Wong-Baker faces pain rating scale (WBFPS).

Step IV: after the administration of the local anesthesia injection, heart rate will be measured for the patients an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.

Step V: in the next appointment, the other technique (virtual reality or topical anesthetic gel) will be used on the contralateral side for the same patients.

So each patient will receive local anesthesia injection twice, one with topical anesthetic gel and one else with VR in the contralateral side.

Step VI: after completion of both procedures, each patient will be asked to state his/her preference for the delivery system of future injections to be recorded.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual reality

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

Group Type: ACTIVE_COMPARATOR

Dental injection and virtual reality device

Intervention Type: DEVICE

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

Topical gel

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

Group Type: ACTIVE_COMPARATOR

Dental injection and topical gel application

Intervention Type: 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.

Interventions

Dental injection and topical gel application

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.

Intervention Type: DRUG

Dental injection and virtual reality device

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

Intervention Type: DEVICE

Other Intervention Names

No other name; No other name

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riyadh Elm University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ammar AbuMostafa, BDS, MSC

Role: STUDY_DIRECTOR

Riyadh Elm University

Locations

Riyadh Elm University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

RiyadhEU

Identifier Type: -

Identifier Source: org_study_id