PainNCT04919421
Comparison Between the Analgesic Effectiveness of Virtual Reality and Topical Anesthesia: A Clinical Study
A study testing Dental injection and topical gel application and Dental injection and virtual reality device in people with Pain, run by Riyadh Elm University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Dental injection and topical gel application and Dental injection and virtual reality device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Nov 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of The Analgesic Effect of Virtual Reality With Topical Anesthesia to Reduce Pain During Administration of Local Anesthesia
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.
Read the 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
- Being tested
- Dental injection and topical gel application, Dental injection and virtual reality device
- Keywords
- pain perception, virtual reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental injection and topical gel applicationDrug
Also called No other name
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.
Dental injection and virtual reality deviceDevice
Also called No other name
Dental injection will be made while the participants are wearing virtual reality device.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Active comparator | Participants will wear a virtual reality headset during the dental injection in which a video is playing. Receives: Device: Dental injection and virtual reality device |
| Topical gel | Active comparator | Participants will receive application of topical anesthetic gel on the site of dental injection. Receives: Drug: Dental injection and topical gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
heart rate will be measured for the participants using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter)
Measured: 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.
Measured: 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
Measured: 5 minutes after the intervention/procedure (injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start10 Nov 2019
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ammar AbuMostafa, BDS, MSC, Study director, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919421
- Sponsor's protocol ID
- RiyadhEU
- Status last verified
- Jun 2021
- First submitted
- 30 Oct 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of The Analgesic Effect of Virtual Reality With Topical Anesthesia to Reduce Pain During Administration of Local Anesthesia
- ClinicalTrials.gov ID
- NCT04919421
- Acronym / sponsor ID
- RiyadhEU
- Conditions
- Pain
- Keywords
- pain perception, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Active comparator | Device: Dental injection and virtual reality deviceParticipants will wear a virtual reality headset during the dental injection in which a video is playing. |
| Topical gel | Active comparator | Drug: Dental injection and topical gel applicationParticipants will receive application of topical anesthetic gel on the site of dental injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental injection and topical gel applicationAlso: No other nameTopical 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. | Drug | Topical gel |
| Dental injection and virtual reality deviceAlso: No other nameDental injection will be made while the participants are wearing virtual reality device. | Device | Virtual reality |
Primary outcome
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)
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar AbuMostafa, BDS, MSC study director
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental injection and topical gel application and Dental injection and virtual reality device in people with Pain, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: immediately after the intervention/procedure (injection)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.