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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Dental injection and topical gel application
* Device: Dental injection and virtual reality device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual reality<br>Participants will wear a virtual reality headset during the dental injection in which a video is playing. | Device: Dental injection and virtual reality device<br>* Dental injection will be made while the participants are wearing virtual reality device.<br>* Other names: No other name;|
| Active Comparator: Topical gel<br>Participants will receive application of topical anesthetic gel on the site of dental injection. | Drug: Dental injection and topical gel application<br>* 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.<br>* Other names: No other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain perception, virtual reality