Clinical trial NCT04919421: Comparison Between the Analgesic Effectiveness of Virtual Reality and Topical Anesthesia: A Clinical Study
Official title: Comparative Evaluation of The Analgesic Effect of Virtual Reality With Topical Anesthesia to Reduce Pain During Administration of Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain perception
virtual reality
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Heart rate
timeFrame: immediately after the intervention/procedure (injection)
measure: Wong-Baker faces pain rating scale (WBFPS)
timeFrame: 3 minutes after the intervention/procedure (injection)
measure: Participant's future preference
timeFrame: 5 minutes after the intervention/procedure (injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
affiliation: Riyadh Elm University
name: Ammar AbuMostafa, BDS, MSC
role: STUDY_DIRECTOR
References: