NCT04919421

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Riyadh Elm University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-10
• Primary completion: 2019-12-30
• Completion: 2020-01-30
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

1 site across 1 country: Saudi Arabia