Hospitalized Patients 18 Years of Age or Older With PainVR PainNCT05293275
Virtual Reality Pain Study
A study testing EaseVRx Virtual Reality Headset in people with Hospitalized Patients 18 Years of Age or Older With Pain, run by Baylor Research Institute at 3 sites in United States.
Trial summary
Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospitalized Patients 18 Years of Age or Older With Pain
- What is being tested?
- EaseVRx Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2022to Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • patients at least 18 years of age,
- reported pain in last 24 hours ≥ 3 on the Numerical Rating Scales (NRS),
- patients undergoing surgery,
- expected hospital length of stay of at least 48 hours,
- English fluency,
- willing to comply with study procedures.
- Hx opioid use
Who cannot join
- • gross cognitive impairment that would interfere with the ability to consent or complete study procedures
- current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines,
- hypersensitivity to flashing light or motion,
- history of motion sickness or cyber sickness,
- medical condition predisposing to or current nausea, vomiting or dizziness,
- stereoscopic vision or severe hearing impairment,
Show all 12Show fewer
- injury to eyes, face or neck that impedes comfortable use of virtual reality,
- cancer related pain,
- PHQ-9 screen indicating suicidal ideation, patients will be referred to appropriate clinical intervention (see suicide protocol)
- currently pregnant,
- current or recent completion of participation in any interventional pain study (with in past 2 months)
- substance abuse (alcohol or illegal drugs): Alcohol- NIAAA definition of heavy drinking as more than 4 drinks on any day or more than 14 drinks per week for men, more than 3 drinks on any day or more than 7 drinks per week for women. Any illegal drugs including marijuana
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
Tracy Birdsong, 281-948-9625, tracy.birdsong2@bswhealth.org
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Tracy Birdsong, MD, 281-948-9625, tracy.birdsong2@bswhealth.org
- Not yet recruiting
Baylor Scott and White Hospital-Temple
Temple, Texas, 76508
Kimberly Trembly, NP, 254-724-2111, kristina.trembly@bswhealth.org
About this study
Official title: Virtual Reality as Nonpharmacologic Pain Management Among Hospitalized Inpatients. A Randomized Control Trial of Virtual Reality vs Standard of Care
Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care
Read the detailed description
Patients will be randomized to either the virtual reality group or the standard of care group. The virtual reality group will use the device over two days. Both groups will answer questionnaires regarding their pain and anxiety. Medical records will be used to look at pain medication usage in both groups.
- Being tested
- EaseVRx Virtual Reality Headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EaseVRx Virtual Reality HeadsetDevice
Virtual reality device with 360 degree visualization of various scenery and interactive modules
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Active comparator | patients will use the virtual reality device over two days Receives: Device: EaseVRx Virtual Reality Headset |
| Standard of care | No intervention | patients will receive standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by Numerical Pain Rating Scale
level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)
Measured: 3-4 days
Secondary outcomes (2)
Anxiety assessed with numerical scale
level of anxiety assessed with numerical scale composed of 0 (no anxiety) to 10 (anxiety out of control)
Measured: 3-4 days
The PROMIS sleep disturbance questionnaire
disruption of sleep assessed using the PROMIS sleep disturbance questionnaire
Measured: 3-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Mar 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized Patients 18 Years of Age or Older With 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark B Powers, Baylor Research Institute
- Investigators
- Mark Powers, PhD, Principal investigator, Research Center Director Trauma Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293275
- Sponsor's protocol ID
- IRB 021-367
- Acronym
- VR Pain
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as Nonpharmacologic Pain Management Among Hospitalized Inpatients. A Randomized Control Trial of Virtual Reality vs Standard of Care
- ClinicalTrials.gov ID
- NCT05293275
- Acronym / sponsor ID
- VR Pain / IRB 021-367
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Mar 2022 (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.
Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care
Detailed description
Patients will be randomized to either the virtual reality group or the standard of care group. The virtual reality group will use the device over two days. Both groups will answer questionnaires regarding their pain and anxiety. Medical records will be used to look at pain medication usage in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Active comparator | Device: EaseVRx Virtual Reality Headsetpatients will use the virtual reality device over two days |
| Standard of care | No intervention | –patients will receive standard of care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • patients at least 18 years of age,
Key exclusion criteria (12 listed)
- • gross cognitive impairment that would interfere with the ability to consent or complete study procedures
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 |
|---|---|---|
| EaseVRx Virtual Reality HeadsetVirtual reality device with 360 degree visualization of various scenery and interactive modules | Device | Virtual Reality Group |
Primary outcome
Pain assessed by Numerical Pain Rating Scale
Time frame: 3-4 days
level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)
2 secondary outcomes
Anxiety assessed with numerical scale
Time frame: 3-4 days
The PROMIS sleep disturbance questionnaire
Time frame: 3-4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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.
Mark Powers, PhD principal investigator
Research Center Director Trauma Research Consortium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EaseVRx Virtual Reality Headset in people with Hospitalized Patients 18 Years of Age or Older With Pain, run by Baylor Research Institute at 3 sites 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 7 inclusion and 12 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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Mark Powers, PhD (5129936443, mak.powers1@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by Numerical Pain Rating Scale (time frame: 3-4 days). 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 24 Mar 2022.