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

Pain Clinical Trial

Official title:

Comparative Evaluation of The Analgesic Effect of Virtual Reality With Topical Anesthesia to Reduce Pain During Administration of Local Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919421
• Other study ID #: RiyadhEU
• Status: Completed
• Phase: N/A
• Start date: November 10, 2019
• Est. completion date: January 30, 2020

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.

Device:
• Dental injection and virtual reality device
Dental injection will be made while the participants are wearing virtual reality device.

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Elm University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Elm University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)