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Completed

NCT Number: NCT04919421

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riyadh Elm University

Riyadh, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: No other name

Dental injection and virtual reality device

Device

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

Other names: No other name

Primary outcomes

  1. Heart rate

    Time frame: immediately after the intervention/procedure (injection)

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

  2. Wong-Baker faces pain rating scale (WBFPS)

    Time frame: 3 minutes after the intervention/procedure (injection)

    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. Participant's future preference

    Time frame: 5 minutes after the intervention/procedure (injection)

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

Sponsors and collaborators

Lead sponsor

Riyadh Elm University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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