PainNCT04287491
Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
A study testing Oculus Go Virtual Reality System in people with Pain, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Oculus Go Virtual Reality System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Apr 2022
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients 13 years and older.
- Patient (or health care proxy when applicable) must sign an ICF.
- Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application.
- Patients willing to participate and parents able to consent.
Who cannot join
- Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions.
- Subjects requiring procedures on the head are also excluded to the interference of the VR headset.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.
- Conditions
- Pain
- Being tested
- Oculus Go Virtual Reality System
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Go Virtual Reality SystemOther
The VR system will provide a 3D environment that provides distracting stimulus. Participant will put on the Oculus Go VR system headset 1-2 minutes prior to out-patient bedside procedure up to the completion of procedure which takes typically 3-5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | This group will receive the virtual reality intervention during out-patient bedside procedures. Receives: Other: Oculus Go Virtual Reality System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain as assessed by the visual analog scale (VAS)
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Measured: Baseline, up to 2 hours
Change in maximum pain level as assessed by VAS
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Measured: Baseline, up to 2 hours
Secondary outcomes (3)
Change in heart rate
Heart rate will be assessed in beats per minute.
Measured: Baseline, up to 2 hours
Change in oxygen saturation
Oxygen saturation will be assessed as a percentage.
Measured: Baseline, up to 2 hours
Incidence of intervention related adverse events
Intervention related adverse events will be assessed per treating physician discretion.
Measured: Baseline, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Why it stopped: Lack of funding
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287491
- Sponsor's protocol ID
- 20190653
- Status last verified
- Jun 2020
- First submitted
- 25 Feb 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
- ClinicalTrials.gov ID
- NCT04287491
- Acronym / sponsor ID
- 20190653
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 27 Feb 2020 (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.
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Oculus Go Virtual Reality SystemThis group will receive the virtual reality intervention during out-patient bedside procedures. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 13 years and older.
- Patient (or health care proxy when applicable) must sign an ICF.
- Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application.
- Patients willing to participate and parents able to consent.
Key exclusion criteria (2 listed)
- Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions.
- Subjects requiring procedures on the head are also excluded to the interference of the VR headset.
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 |
|---|---|---|
| Oculus Go Virtual Reality SystemThe VR system will provide a 3D environment that provides distracting stimulus. Participant will put on the Oculus Go VR system headset 1-2 minutes prior to out-patient bedside procedure up to the completion of procedure which takes typically 3-5 minutes. | Other | Virtual Reality Group |
Primary outcome
Change in average pain as assessed by the visual analog scale (VAS)
Time frame: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Change in maximum pain level as assessed by VAS
Time frame: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
3 secondary outcomes
Change in heart rate
Time frame: Baseline, up to 2 hours
Change in oxygen saturation
Time frame: Baseline, up to 2 hours
Incidence of intervention related adverse events
Time frame: Baseline, up to 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Go Virtual Reality System in people with Pain, run by University of Miami at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 16 Jun 2020. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in average pain as assessed by the visual analog scale (VAS) (time frame: Baseline, up to 2 hours). The study lists 2 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 16 Jun 2020.