Chronic PainNCT05468086

VR Solace for Pain and Anxiety Using Survey and Biodata

A study testing VR Solace in people with Chronic Pain, run by Omer Liran 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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Chronic Pain
What is being tested?: VR Solace
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2022to 28 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18+
Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
Diagnosis with chronic pain/anxiety

Who cannot join

Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
Exclusions of patient currently taking beta blockers
Unable to communicate/read English for survey items
Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis

The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.

Conditions: Chronic Pain
Being tested: VR Solace
Medical subject headings: Chronic Pain

What participants receive

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

VR SolaceDevice
Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.

Study groups in NCT05468086
Study group	Role	What they receive
Solace VR	Experimental	This arm will include software that provides immersive distraction based content for pain reduction. Receives: Device: VR Solace

What is being measured

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

Patient-reported Pain Level Pre Versus Post-VR Session
Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Measured: Just prior to session to 15-minutes post session
Patient-reported Anxiety Level Pre Versus Post-VR Session
Anxiety level pre versus post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale, 1 to 4, for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). Scores range from 20 to 80, with higher scores reflecting increased anxiety.
Measured: Just prior to VR session and 15 minutes after the VR session

Timeline

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

30 Aug 202228 Jun 2023

First posted21 Jul 2022
Study start30 Aug 2022
Primary completion28 Jun 2023
Study completion28 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05468086
Sponsor's protocol ID: STUDY00002144
Status last verified: Oct 2024
First submitted: 13 Jul 2022
Last updated: 4 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis
ClinicalTrials.gov ID: NCT05468086
Acronym / sponsor ID: STUDY00002144
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Omer LiranUniversity, hospital or other
Study start: 30 Aug 2022 (actual)
Primary completion: 28 Jun 2023 (actual)
Study completion: 28 Jun 2023 (actual)
First posted: 21 Jul 2022 (actual)
Results: Posted 4 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Solace VR	Experimental	Device: VR SolaceThis arm will include software that provides immersive distraction based content for pain reduction.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18+
Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
Diagnosis with chronic pain/anxiety

Key exclusion criteria (6 listed)

Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
Exclusions of patient currently taking beta blockers
Unable to communicate/read English for survey items

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
VR SolaceParticipants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.	Device	Solace VR

Primary outcome

Patient-reported Pain Level Pre Versus Post-VR Session
Time frame: Just prior to session to 15-minutes post session
Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Patient-reported Anxiety Level Pre Versus Post-VR Session
Time frame: Just prior to VR session and 15 minutes after the VR session
Anxiety level pre versus post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale, 1 to 4, for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). Scores range from 20 to 80, with higher scores reflecting increased anxiety.

Results and safety

Results posted to the registry on 4 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solace VR	35	31

Primary outcome: Patient-reported Pain Level Pre Versus Post-VR Session

Time frame: Just prior to session to 15-minutes post session. Mean (Standard Deviation). Unit: score on a scale

Measure	Pre-Solace VR n = 31	Post-VR Solace n = 31
Value	6.6 (2.0)	5.1 (2.5)

Population analysed: Age 18 years or older who suffer from chronic pain, have ongoing pain of equal or greater than 3 on an 11-point numerical rating scale, and were capable of giving informed consent.

Primary outcome: Patient-reported Anxiety Level Pre Versus Post-VR Session

Time frame: Just prior to VR session and 15 minutes after the VR session. Mean (Standard Deviation). Unit: score on a scale

Measure	Pre-Solace VR n = 31	Post-VR Solace n = 31
Value	46.7 (12.2)	35.6 (11.2)

Adverse events

Time frame: Up to 15 minutes post-VR session. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solace VR	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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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.

Omer Liran, MD, MSHS principal investigator

Cedars-Sinai 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 VR Solace in people with Chronic Pain, run by Omer Liran 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 6 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 4 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient-reported Pain Level Pre Versus Post-VR Session (time frame: Just prior to session to 15-minutes post session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05468086.

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 4 Nov 2024.