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Virtual RealityNCT03894592

Virtual Reality Analgesia In Trauma Rehab

A study testing Virtual reality in people with Virtual Reality and Musculoskeletal Pain, run by New York City Health and Hospitals Corporation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This will be a pilot study utilizing Virtual Reality Analgesia (VRA) as a first line nonpharmacologic analgesic intervention on the Acute Rehabilitation Unit. In order to assess the efficacy of the intervention with a set of outcome measures will be defined: Pain will be measured using the VAS for all subjects pre… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Virtual Reality, Musculoskeletal Pain, Opioid Use
What is being tested?
Virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to Oct 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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult with Traumatic injury on the Acute Rehab Unit
  • Adult ages 18-100
  • Adult with intact vision who can attend VR intervention
  • Adult receiving PO Medications
  • Adult with motor control of at least one arm

Who cannot join

  • Adult who has uncontrolled seizures more than 4 times per year
  • Adult who is not attentive to VR secondary to poor concentration/poor cognition to external stimuli.
  • Adult with no volitional control of the neck and or upper extremities.

Trial locations and contacts

1 site in 1 country.

Michelle Stern, MD contact

9175779543

Michelle.Stern@nychhc.org

Ratnakar P Veeramachaneni, MD contact

7182077551

rveerama@montefiore.org

United States1 site, 1 recruiting
  • Jacobi Medical Center

    The Bronx, New York, 10461

    Stern Michelle, MD, 917-577-9543, michelle.stern@nychhc.org

    Recruiting

Other trials in United States

About this study

Official title: Utilizing Virtual Reality Analgesia (VRA) as a First Line Nonpharmacologic Analgesic Intervention on the Acute Rehabilitation Unit: A Pilot Study

This will be a pilot study utilizing Virtual Reality Analgesia (VRA) as a first line nonpharmacologic analgesic intervention on the Acute Rehabilitation Unit. In order to assess the efficacy of the intervention with a set of outcome measures will be defined:

  • Pain will be measured using the VAS for all subjects pre-, during and post-intervention via self-report.
  • Number of opioids/oral pain medication consumed will be analyzed
  • Patient anxiety will be measured on the Short ( State-Trait Anxiety Index) STAI anxiety scale pre- and post-intervention.
  • Heart rate and blood pressure will also be measured pre and post intervention.
Read the detailed description

The purpose of this project is to evaluate the efficacy of virtual reality analgesia (VRA) for Adult patients in acute pain in the Acute Rehabilitation unit. Given the severity of the opioid epidemic, physicians are looking for alternative non-opioid/non-pharmacologic interventions to decrease both pain, and the need for opioids.

The recognition of pain by an individual requires both a noxious stimulus as well as attention on the part of the subject. Studies have shown that pain sensation is less on the visual analogue scale (VAS) when subjects are distracted, and that distraction can assist in pain control, since humans have limited attention capacity. When treating Adult patients with acute pain, it could thus be useful to have an effective method of pain distraction to improve tolerance and comfort, and to decrease the amount of narcotic medications prescribed.

Virtual reality (VR) is a digital simulation of a three-dimensional environment in which the user is capable of interacting with the generated world via computerized equipment such as gloves or a virtual reality head-mounted display (VRHMD). 360-degree VR video is a subset of virtual reality which creates an immersive experience of real world environments, allowing the user to have a sense of presence and exploration while wearing a (VRHMD). VR exposure is shown to be a potent distractor and has been repeatedly shown to provide analgesia during painful procedures. Since adults are often very attracted to technology, computer games, and virtual reality, we propose a study to allow adults to interact with a custom virtual reality environment in order to consume a substantial proportion of their attentional resources during acute pain episodes. We hypothesize that immersing the patients in VR will allow these patients to spend less attention on pain and allow for less need for other analgesia i.e. opioids.

VR has been demonstrated as a valid method of analgesia for both adults and pediatrics during painful procedures. To the investigator's knowledge, no one has evaluated the use of VRA to reduce opioid consumption in the Acute Rehab unit. In addition to relieving pain, anxiety, stress, and possibly decreasing general sedation, VRA may also decrease medical costs by decreasing length of stay.

Virtual Reality Analgesia (VRA) has been shown by research to be more effective when more immersive. To accomplish this, various head-sets and technologies have been developed to provide a more enveloping experience. Until recently, virtual reality head-mounted displays (VRHMD) had not been widely accepted due to their poor performance and high cost. But recent developments with the Oculus Rift DK1(DK 1 is a model number) in 2012 changed this paradigm. The now commercially available Oculus Rift is an inexpensive state of the art VRHMD. Using the Oculus Rift can create a high definition and smooth environment that will allow for maximal distraction at a modest price point. Therefore, equipment like the Oculus Rift could be an ideal VRA tool in the clinical setting.

Many corporations such as Samsung, Google, and others have invested both capital and development resources that have advanced virtual reality technologies and made them very inexpensive. With these changes, the investigators are finally at a point where both the hardware and the software needed to produce high quality VRHMD is now available at very low and moderate price points. An example of the lowest cost VRHMD is the Google Cardboard, a simple device that allows anyone with a cellphone to experience VR, for as little as $15.

The investigators propose a study utilizing the highest quality VRHMD to provide VRA during acute pain related to trauma. It is the investigators' hypothesis that by using VRA, significant decrease in the overall pain and discomfort can be observed resulting in a decrease in consumption of oral opioids.

Being tested
Virtual reality
Medical subject headings
Musculoskeletal Pain, Anxiety Disorders, Accidental Injuries

What participants receive

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

  • Virtual realityOther

    Trauma patients enrolled in the study will be offered Virtual Reality experieince per the protocol

Study groups in NCT03894592
Study groupRoleWhat they receive
Virtual Reality analgesiaActive comparatorTrauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive the intervention which is a virtual reality headset providing immersive interactive content in the video format
Receives: Other: Virtual reality
ControlNo interventionTrauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention

What is being measured

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

  1. Change in pain perception

    will be measured using the Visual Analogue Scale (VAS) for all subjects pre-, during and post-intervention via self-report. The scale values range from 0 to 10. ) being no pain and 10 being the worst pain

    Measured: 1 year

Secondary outcomes (4)
  1. Increase or decrease in opioid/oral pain medication use

    Number of opioids/oral pain medication consumed will be analyzed from the patients electronic medical record

    Measured: 1 year

  2. Heart Rate

    Pre and post intervention heart rate will be monitored using regular hospital equipment to note any changes pre and post intervention.

    Measured: 1 year

  3. Patient reported anxiety

    Anxiety will be measured on the Short STAI (State-Trait Anxiety Index) anxiety scale pre- and post-intervention.

    The scale has 2 parts with 20 questions in each part. Each question is rated on a 4 point scale,1 to 4.

    Total scores range from 20 to 80 for each part, with higher score indicating higher anxiety

    Measured: 1 year

  4. Blood Pressure

    Pre and post intervention blood pressure will be monitored using regular hospital equipment to note any changes pre and post intervention.

    Measured: 1 year

Timeline

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

  1. First posted28 Mar 2019
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion2 Jul 2020 (estimated)
  4. Study completionOct 2020 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Randomized control study. The pre and post VAS scores will be rated by the patient. Randomization will be achieved using Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool. All the patients will choose one of three virtual reality experiences. 1. Passive VR Movie 2. Interactive relaxation/exploration 3. Active/Adventure experience
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894592
Sponsor's protocol ID
2018-9196
Status last verified
Jul 2019
First submitted
29 Oct 2018
Last updated
26 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Virtual Reality and Musculoskeletal Pain, run by New York City Health and Hospitals Corporation 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michelle Stern, MD (9175779543, Michelle.Stern@nychhc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain perception (time frame: 1 year). 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 26 Jul 2019.

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