Chronic PainNCT05078242
Virtual Reality - Chronic Pain At-Home Pilot Study
A study testing EaseVRx in people with Chronic Pain, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This is a short pilot usability study of a virtual reality device for patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- EaseVRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Chronic pain (using self-report) with pain intensity >=4 and confirmed by ICD-10 codes in medical record
- Fluency in English
Who cannot join
- Inability to give informed consent
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
- Medical condition predisposing to nausea or dizziness
- Hypersensitivity to flashing light or motion
- No stereoscopic vision or severe hearing impairment
- Injury to eyes, face, or neck that prevents use of VR headset
- Currently pregnant, by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
This is a short pilot usability study of a virtual reality device for patients with chronic pain.
Read the detailed description
The investigators will conduct a study of patients with chronic pain to collect feasibility of recruitment data, adherence to therapy data, and preliminary effectiveness data. All patients will be in the active arm, this is not a randomized study.
The intervention being piloted is the EaseVRx (AppliedVR, Los Angeles, CA) VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Each session will include one VR experience, which is 2-16 minutes in length (average of 6 minutes). This study will last one week, or 7 total sessions (out of 56 total sessions).
Participants will complete one survey at 3 days over the telephone assessing pain, mood, adherence to the device, and overall satisfaction. Then participants will complete an additional assessment when the device is returned after day 7, again assessing pain, mood, overall adherence to the device, and overall satisfaction.
The investigators are recruiting participants from the VR Usability Study (IRB # 2021-13108) who expressed interest in participating in further research. As this is a pilot feasibility trial, the plan is to recruit between 5 and 10 patients.
- Conditions
- Chronic Pain
- Being tested
- EaseVRx
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EaseVRxDevice
Participants will experience 7 sessions of the EaseVRx device for chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: EaseVRx sessions | Experimental | This is a study of patients with chronic pain to assess usability of a VR device at home. The main goals are 1) to collect data on feasibility of recruitment, 2) to collect data on daily adherence to therapy, and 3) to collect preliminary effectiveness data on pain and mood outcomes. There will be 7 sessions over one week, with each session lasting about 2-16 minutes. All patients recruited will be in the active arm; this is not a randomized pilot study. Receives: Device: EaseVRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of participants contacted that are enrolled
The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled.
Measured: at study 1 day visit
Secondary outcomes (3)
Satisfaction with VR experience
The investigators will use the Global Impression of Change Scale, which is a 7 point Likert type scale, at the conclusion of the VR experience to measure patient's perceived impression of change before and after VR.
Measured: at study 1 day visit
Change in Mood
The investigators will use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR
Measured: at study 1 day visit
Change in Pain Intensity
The investigators will use a 1-item pain intensity score (0-10) both before and after VR
Measured: at study 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start15 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector Perez, MS, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078242
- Sponsor's protocol ID
- 2021-13471
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality - Chronic Pain At-Home Pilot Study
- ClinicalTrials.gov ID
- NCT05078242
- Acronym / sponsor ID
- 2021-13471
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Oct 2021 (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.
This is a short pilot usability study of a virtual reality device for patients with chronic pain.
Detailed description
The investigators will conduct a study of patients with chronic pain to collect feasibility of recruitment data, adherence to therapy data, and preliminary effectiveness data. All patients will be in the active arm, this is not a randomized study.
The intervention being piloted is the EaseVRx (AppliedVR, Los Angeles, CA) VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Each session will include one VR experience, which is 2-16 minutes in length (average of 6 minutes). This study will last one week, or 7 total sessions (out of 56 total sessions).
Participants will complete one survey at 3 days over the telephone assessing pain, mood, adherence to the device, and overall satisfaction. Then participants will complete an additional assessment when the device is returned after day 7, again assessing pain, mood, overall adherence to the device, and overall satisfaction.
The investigators are recruiting participants from the VR Usability Study (IRB # 2021-13108) who expressed interest in participating in further research. As this is a pilot feasibility trial, the plan is to recruit between 5 and 10 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: EaseVRx sessions | Experimental | Device: EaseVRxThis is a study of patients with chronic pain to assess usability of a VR device at home. The main goals are 1) to collect data on feasibility of recruitment, 2) to collect data on daily adherence to therapy, and 3) to collect preliminary effectiveness data on pain and mood outcomes. There will be 7 sessions over one week, with each session lasting about 2-16 minutes. All patients recruited will be in the active arm; this is not a randomized pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Chronic pain (using self-report) with pain intensity >=4 and confirmed by ICD-10 codes in medical record
- Fluency in English
Key exclusion criteria (7 listed)
- Inability to give informed consent
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
- Medical condition predisposing to nausea or dizziness
- Hypersensitivity to flashing light or motion
- No stereoscopic vision or severe hearing impairment
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 |
|---|---|---|
| EaseVRxParticipants will experience 7 sessions of the EaseVRx device for chronic pain. | Device | Experimental: EaseVRx sessions |
Primary outcome
% of participants contacted that are enrolled
Time frame: at study 1 day visit
The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled.
3 secondary outcomes
Satisfaction with VR experience
Time frame: at study 1 day visit
Change in Mood
Time frame: at study 1 day visit
Change in Pain Intensity
Time frame: at study 1 day visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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.
Hector Perez, MS, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EaseVRx in people with Chronic Pain, run by Albert Einstein College of Medicine 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 3 inclusion and 7 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 21 Mar 2023. 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?
% of participants contacted that are enrolled (time frame: at study 1 day visit). 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 21 Mar 2023.