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Virtual Reality Pain DistractionIDNCT01823874

Firsthand ID for Pain Control

A study testing virtual reality distraction in people with Virtual Reality Pain Distraction, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical benefits of VR analgesia have been empirically demonstrated as either an alternative or in combination with opioids. Issues of cost, ergonomics, and maintenance of the hardware systems have limited the wider use of this benefit to the public. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Virtual Reality Pain Distraction
What is being tested?
virtual reality distraction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Apr 2013to Dec 2013
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 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ages 18-39
  • healthy

Who cannot join

  • seizure disorders

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington Oral Medicine Clinic

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: The 3D Immersive Display: Validation of a Virtual Reality Technique for Pain Control

Clinical benefits of VR analgesia have been empirically demonstrated as either an alternative or in combination with opioids. Issues of cost, ergonomics, and maintenance of the hardware systems have limited the wider use of this benefit to the public. Firsthand Technology has designed a system to meet the performance requirements for high levels of pain control in a durable, ergonomic package at a greatly reduced cost compared to the current systems in use. This study will validate the new system by running a thermal pain study that tests the effect of the new system (ID) compared to the established standard helmet currently used.

Read the detailed description

This project compares the analgesic effect of the immersive Virtual Reality delivery method, the Firsthand ID, to the current standard of care HMD systems in a laboratory thermal pain test.

Background and Significance- Although advances in medicine have lead to the development of numerous opioid analgesics, excess procedural pain continues to be a major point of concern for patients and health professionals in a clinical setting.1 Pharmacological analgesics, for treatment of acute pain, are unpopular among many patients due to the potential side effects, most commonly nausea, cognitive dysfunction, and constipation. 2 Within the past 10-15 years immersion immersive virtual reality (VR) distraction therapy has been employed to reduce procedural pain for burn victims with relative success. 3 Patients treated with VR along with standard medications reported reduction in pain and reduced time spent thinking about the pain during procedures. 4 In laboratory studies using functional neuroimaging (fMRI), subjects reporting pain reduction while using VR therapy, are also seen demonstrating a decrease in pain-related brain activity. 5 VR is believed to be effective based on gate theory of cognitive load, due to the fact that a person can only process a finite amount of incoming information and conscious attention is needed to perceive pain. 1,6 Consistent with this idea of the amount of information being an important factor in effectiveness, it has been shown that High-Tech-VR (60 degree field-of-view, user interactivity, sound effects, and head tracking) devices are more effective at analgesic therapy than is a Low-Tech-VR system (35 degree field-of-view, lack of: interactivity, sound effects and head tracking).1 More recently studies have shown that interactivity is an important factor of VR responsible for decreasing both pain unpleasantness and time spent thinking about pain, while increasing fun. 7 Interactivity is said to increase immersion into the VR world. 7 VR immersion, as defined by Slater and Wilber, is an objective, quantifiable description of the sensory input that a VR system can deliver to a subject. 8 This is a distinct entity separate from presence, which is the subjective psychological illusion of the world created in the users mind. 8. Increasing immersion facilitates a stronger illusion of presence and serves as a subsequent greater distractor effect thus, decreasing perception of the painful stimuli.

A major obstacle to the wider testing and proliferation of the potential benefits of VR analgesia is due to the excessive cost and technical limitations of immersive display hardware, specifically head-mounted displays (HMDs). Firsthand has developed an arm-mounted high resolution 3D display, the Firsthand ID, which delivers a high quality image and immersive experience at significant cost savings compared to the current standard of care using HMDs. This project proposes a scientific feasibility study to compare the analgesic effect of the Firsthand ID to the current standard of care HMD systems in a laboratory thermal pain test.

Being tested
virtual reality distraction
Keywords
Virtual reality analgesia, pain control
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual reality distractionProcedure or surgery

    Also called HMD, ID

    Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.

Study groups in NCT01823874
Study groupRoleWhat they receive
ID virtual reality distractionExperimentalvirtual reality distraction
Receives: Procedure: virtual reality distraction
HMD virtual reality distractionExperimentalvirtual reality distraction
Receives: Procedure: virtual reality distraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Graphic Rating Scale pain ratings

    Rating scales will determine levels of pain, fun, and nausea experienced.

    Measured: immediately post test - Day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

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
Basic science
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01823874
Sponsor's protocol ID
44218-G
Other IDs
1R43GM102099-01A1
Acronym
ID
Status last verified
Dec 2013
First submitted
29 Mar 2013
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality distraction in people with Virtual Reality Pain Distraction, run by University of Washington 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 2 inclusion and 1 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 16 Dec 2013. 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 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?

Graphic Rating Scale pain ratings (time frame: immediately post test - Day 1.). 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 Dec 2013.

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