Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2013-04-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ID virtual reality distraction
virtual reality distraction
virtual reality distraction
Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.
HMD virtual reality distraction
virtual reality distraction
virtual reality distraction
Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
virtual reality distraction
Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* healthy
Exclusion Criteria
18 Years
39 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Firsthand Technology Inc.
INDUSTRY
National Institute of General Medical Sciences (NIGMS)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jacqueline E. Pickrell
Study Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacqueline E Pickrell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Washington Oral Medicine Clinic
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
44218-G
Identifier Type: -
Identifier Source: org_study_id