Chronic Pain
Conditions
Brief summary
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.
Interventions
DEVICEVR Solace
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.
Sponsors
Omer Liran
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey * Diagnosis with chronic pain/anxiety
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Pain Level Pre Versus Post-VR Session | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
The recruitment will be limited to one site, an inpatient hospital setting at Cedars-Sinai Medical Center (CSMC)
Participants by arm
| Arm | Count |
|---|---|
| Solace VR This arm will include software that provides immersive distraction based content for pain reduction.
VR Solace: 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. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject was found ineligible after consent | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Solace VR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
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.
Time frame: Just prior to VR session and 15 minutes after the VR session
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Solace VR | Patient-reported Anxiety Level Pre Versus Post-VR Session | 46.7 score on a scale | Standard Deviation 12.2 |
| Post-VR Solace | Patient-reported Anxiety Level Pre Versus Post-VR Session | 35.6 score on a scale | Standard Deviation 11.2 |
Primary
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).
Time frame: Just prior to session to 15-minutes post session
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Solace VR | Patient-reported Pain Level Pre Versus Post-VR Session | 6.6 score on a scale | Standard Deviation 2 |
| Post-VR Solace | Patient-reported Pain Level Pre Versus Post-VR Session | 5.1 score on a scale | Standard Deviation 2.5 |