Chronic Pain, Opioid Use Disorder
Conditions
Brief summary
This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.
Detailed description
The investigators will conduct a study of patients with co-morbid chronic pain and opioid use disorder enrolled in a methadone maintenance treatment program (MMTP) to pilot device feasibility and measure changes in pain intensity and opioid craving. All patients will be randomized to one of each of the following arms: 1) RelieVRx (intervention group) or 2) Non-immersive sham VR (control group). The intervention being piloted is the RelieVRx - AppliedVR, Los Angeles, California - VR hardware and software. RelieVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. RelieVRx is typically delivered in a 56-day program through daily virtual experiences, with each experience lasting between 2 and 16 minutes. In this pilot study, the investigators will conduct virtual experiences twice weekly at the MMTP. Over 6 weeks, participants in both groups will participate in 20-30 minute VR sessions twice per week. Each session will last about 20-30 minutes and go through 1-5 virtual experiences. The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. Control participants will similarly experience 1-5 virtual experiences in each 20-30 session.
Interventions
DEVICERelieVRx
The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.
DEVICESham VR
The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Sponsors
National Institute on Drug Abuse (NIDA)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old 2. English proficiency 3. receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability 4. chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale) 5. willingness to participate in all study components 6. ability to provide informed consent, assessed using consent teach-back
Exclusion criteria
1. conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion) 2. conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset) 3. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | From baseline to 6 weeks | Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Percentage of Participants Contacted That Are Enrolled | Baseline, up to 2 weeks | The percentage of participants contacted who were enrolled into the study was used to assess the feasibility of the study. Results were summarized using basic descriptive statistics. |
| Change in Opioid Craving | From baseline to 6 weeks | Change in Opioid Craving was assessed using the Opioid Medication Craving Visual Analog Scale. This 3-item scale asked participants to rate how strong their desire to use opioids was during the previous 24 hours; the likelihood that they would use opioids if placed in the environment in which they had previously used drugs/alcohol; and how strong their urges for opioids are when something in their environment reminds them of it. Responses were marked on visual scale ranging from 0-100 where 0 signified 'No Desire or Likelihood of Use' and 100 signified 'Strong Desire or Likelihood of use. Positive mean scores were associated with increased opioid craving from baseline and negative mean scores were associated with decreased opioid craving from baseline. Scores were summarized by study arm using basic descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function | From baseline to 6 weeks | Change in cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS 29) Cognitive Function domain form. This form consists of 2 questions which asked participants to assess cognitive function over the prior 7 days. Both questions for this measure are summed up on a 5-point Likert scale ranging from Not at all to Very much = 4, for an overall possible scoring range of 0-8 such that higher scores are associated with increased overall cognitive function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with increased overall cognitive function from baseline and negative mean scores were associated with decreased overall cognitive function from baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Sleep | From baseline to 6 weeks | Change in sleep was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a. This form consists of 6 items which asked participants to assess quality and attributes of their sleep patterns over the prior 7 days. Response options for the sleep quality item range from Very poor = 1 to Very good = 5 and from Not at all = 1 to Very much = 5 for the remaining five items. The two positively phrased items are reverse-coded and sum scores are calculated and the raw sum score is rescaled on the PROMIS conversion table to determine a standardized T-score (overall mean of 50 and standard deviation of 10). For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater sleep disturbance and decreased overall sleep quality relative to baseline and negative mean scores were associated with decreased sleep disturbance and increased overall sleep quality relative to baseline. |
| Change in Social Function | From baseline to 6 weeks | Change in social function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 4a Heal form. This form consists of 4 items which asked participants to assess their leisure, family, work and general social function behaviors over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with increased inhibition in social function/participation. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition to social participation relative to baseline and negative mean scores were associated with increased inhibition to social participation relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Physical Function | From baseline to 6 weeks | Change in physical function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 6b Heal form. This form consists of 6 items which asked participants to assess their physical function and ability to conduct chores, climb stairs, walk, and run errands. Responses to the 6 items are summed up on a 5-point Likert scale ranging from Without any difficulty (or Not at all) = 0 to Unable to do (or Cannot do) = 4, for an overall possible scoring range of 0-24 such that higher scores are associated with increased inhibition in physical function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition in physical function relative to baseline and negative mean scores were associated with increased inhibition in physical function relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Depression | From baseline to 6 weeks | Change in depression was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of depressive symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of depression-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of depression-related symptoms relative to baseline and negative mean scores were associated with reduced frequency of depression-related symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Anxiety | From baseline to 6 weeks | Change in anxiety was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of onset of anxiety-related symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of anxiety-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of anxiety symptoms relative to baseline and negative mean scores were associated with reduced frequency of anxiety symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Pain Interference | From baseline to 6 weeks | Change in pain interference was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 4a scale. This form consists of 4 items which asked participants to rate the degree to which their pain interfered with a range of activities over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Not at all = 0 to Very much = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with greater pain interference. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater pain interference relative to baseline and negative mean scores were associated with reduced pain interference relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Cytokines | baseline, 3 weeks, 6 weeks | The investigators will collect blood samples at each time frame and test for serum cytokines, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms. |
| Change in Serum C-reactive Protein | baseline, 3 weeks, 6 weeks | The investigators will collect blood samples at each time frame and test for serum c-reactive protein, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms. |
| Change in Serum Cortisol | baseline, 3 weeks, 6 weeks | The investigators will collect blood and urine samples at each time frame and test for serum cortisol, which is a chronic pain inflammatory biomarker. Higher levels of serum cortisol may indicate greater chronic pain symptoms. |
| Change in Stress | From baseline to 6 weeks | Change in stress was assessed using the National Institutes of Health (NIH) Perceived Stress Scale (PSS-10) which consists of 10 items asking participants to assess the frequency of onset of stress-related symptoms over the prior month on a 5-item Likert scale ranging from 0-4. Six of the ten items are coded such that Never = 0 and Very often = 4; and four of the ten items are reverse-coded such that Never =4 and Very often = 0, for an overall scoring range of 0-40. The higher the score the worse the perceived stress. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of stress relative to baseline and negative mean scores were associated with reduced frequency of stress relative to baseline. Scores were summarized by study arm using basic descriptive statistics. |
| Change in Salivary Cortisol | baseline, 3 weeks, 6 weeks | The investigators will collect saliva the morning of each time frame and test for cortisol, which is a chronic pain inflammatory biomarker. Higher levels of salivary cortisol may indicate greater chronic pain symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RelieVRx RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.
RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. | 10 |
| Sham Virtual Reality The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.
Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Sham Virtual Reality | Total | RelieVRx |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 8 | 59.8 years STANDARD_DEVIATION 6.5 | 59.5 years STANDARD_DEVIATION 5.3 |
| Education Completed 1 or more years of college/university | 1 Participants | 3 Participants | 2 Participants |
| Education Completed GED or equivalent | 0 Participants | 3 Participants | 3 Participants |
| Education Did not complete High School (HS) | 3 Participants | 6 Participants | 3 Participants |
| Education Received HS diploma | 4 Participants | 6 Participants | 2 Participants |
| Pain impact (PEG score) | 6.71 score on a scale STANDARD_DEVIATION 1.86 | 7.24 score on a scale STANDARD_DEVIATION 1.78 | 7.67 score on a scale STANDARD_DEVIATION 1.67 |
| Race/Ethnicity, Customized Black, non Hispanic | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic, any race | 4 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 8 participants | 18 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 1 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
Change in Opioid Craving
Change in Opioid Craving was assessed using the Opioid Medication Craving Visual Analog Scale. This 3-item scale asked participants to rate how strong their desire to use opioids was during the previous 24 hours; the likelihood that they would use opioids if placed in the environment in which they had previously used drugs/alcohol; and how strong their urges for opioids are when something in their environment reminds them of it. Responses were marked on visual scale ranging from 0-100 where 0 signified 'No Desire or Likelihood of Use' and 100 signified 'Strong Desire or Likelihood of use. Positive mean scores were associated with increased opioid craving from baseline and negative mean scores were associated with decreased opioid craving from baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Opioid Craving | -2.86 score on a scale | Standard Deviation 30.9 |
| Sham Virtual Reality | Change in Opioid Craving | 9.17 score on a scale | Standard Deviation 17.44 |
Comparison: A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.p-value: 0.3295% CI: [-40.3, 13.1]Mixed Models Analysis
Primary
Change in Pain Intensity
Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Pain Intensity | -1.38 score on a scale | Standard Deviation 1.69 |
| Sham Virtual Reality | Change in Pain Intensity | 0.33 score on a scale | Standard Deviation 2.66 |
Comparison: A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.p-value: 0.1795% CI: [-3.1, 0.54]Mixed Models Analysis
Primary
Percentage of Participants Contacted That Are Enrolled
The percentage of participants contacted who were enrolled into the study was used to assess the feasibility of the study. Results were summarized using basic descriptive statistics.
Time frame: Baseline, up to 2 weeks
Population: All participants who were contacted enrolled into the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RelieVRx | Percentage of Participants Contacted That Are Enrolled | 10 Participants |
| Sham Virtual Reality | Percentage of Participants Contacted That Are Enrolled | 8 Participants |
Secondary
Change in Anxiety
Change in anxiety was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of onset of anxiety-related symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of anxiety-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of anxiety symptoms relative to baseline and negative mean scores were associated with reduced frequency of anxiety symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Anxiety (PROMIS, Anxiety 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Anxiety | -2.88 score on a scale | Standard Deviation 6.64 |
| Sham Virtual Reality | Change in Anxiety | -1.0 score on a scale | Standard Deviation 4.34 |
Secondary
Change in Cognitive Function
Change in cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS 29) Cognitive Function domain form. This form consists of 2 questions which asked participants to assess cognitive function over the prior 7 days. Both questions for this measure are summed up on a 5-point Likert scale ranging from Not at all to Very much = 4, for an overall possible scoring range of 0-8 such that higher scores are associated with increased overall cognitive function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with increased overall cognitive function from baseline and negative mean scores were associated with decreased overall cognitive function from baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Cognitive Function (PROMIS 29 Cognitive Function) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Cognitive Function | 1.5 score on a scale | Standard Deviation 3.25 |
| Sham Virtual Reality | Change in Cognitive Function | -0.67 score on a scale | Standard Deviation 2.5 |
Secondary
Change in Depression
Change in depression was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of depressive symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of depression-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of depression-related symptoms relative to baseline and negative mean scores were associated with reduced frequency of depression-related symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Depression (PROMIS, Depression 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Depression | -2.38 score on a scale | Standard Deviation 5.01 |
| Sham Virtual Reality | Change in Depression | -2.5 score on a scale | Standard Deviation 4.46 |
Secondary
Change in Pain Interference
Change in pain interference was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 4a scale. This form consists of 4 items which asked participants to rate the degree to which their pain interfered with a range of activities over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Not at all = 0 to Very much = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with greater pain interference. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater pain interference relative to baseline and negative mean scores were associated with reduced pain interference relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Pain Interference (PROMIS, Pain Interference 4a) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Pain Interference | -2.25 score on a scale | Standard Deviation 8.43 |
| Sham Virtual Reality | Change in Pain Interference | 1.67 score on a scale | Standard Deviation 5.2 |
Secondary
Change in Physical Function
Change in physical function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 6b Heal form. This form consists of 6 items which asked participants to assess their physical function and ability to conduct chores, climb stairs, walk, and run errands. Responses to the 6 items are summed up on a 5-point Likert scale ranging from Without any difficulty (or Not at all) = 0 to Unable to do (or Cannot do) = 4, for an overall possible scoring range of 0-24 such that higher scores are associated with increased inhibition in physical function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition in physical function relative to baseline and negative mean scores were associated with increased inhibition in physical function relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Physical Function (PROMIS, Social 6b Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Physical Function | 1.13 score on a scale | Standard Deviation 5.38 |
| Sham Virtual Reality | Change in Physical Function | -1.83 score on a scale | Standard Deviation 3.49 |
Secondary
Change in Sleep
Change in sleep was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a. This form consists of 6 items which asked participants to assess quality and attributes of their sleep patterns over the prior 7 days. Response options for the sleep quality item range from Very poor = 1 to Very good = 5 and from Not at all = 1 to Very much = 5 for the remaining five items. The two positively phrased items are reverse-coded and sum scores are calculated and the raw sum score is rescaled on the PROMIS conversion table to determine a standardized T-score (overall mean of 50 and standard deviation of 10). For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater sleep disturbance and decreased overall sleep quality relative to baseline and negative mean scores were associated with decreased sleep disturbance and increased overall sleep quality relative to baseline.
Time frame: From baseline to 6 weeks
Population: 3-week Sleep (PROMIS, Sleep Disturbance 6a) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Sleep | 0 score on a scale | Standard Deviation 8.52 |
| Sham Virtual Reality | Change in Sleep | 3 score on a scale | Standard Deviation 3.9 |
Secondary
Change in Social Function
Change in social function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 4a Heal form. This form consists of 4 items which asked participants to assess their leisure, family, work and general social function behaviors over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from Never = 0 to Always = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with increased inhibition in social function/participation. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition to social participation relative to baseline and negative mean scores were associated with increased inhibition to social participation relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Social Function (PROMIS, Social 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Social Function | 2 score on a scale | Standard Deviation 3.51 |
| Sham Virtual Reality | Change in Social Function | 0.333 score on a scale | Standard Deviation 3.44 |
Other Pre-specified
Change in Salivary Cortisol
The investigators will collect saliva the morning of each time frame and test for cortisol, which is a chronic pain inflammatory biomarker. Higher levels of salivary cortisol may indicate greater chronic pain symptoms.
Time frame: baseline, 3 weeks, 6 weeks
Other Pre-specified
Change in Serum Cortisol
The investigators will collect blood and urine samples at each time frame and test for serum cortisol, which is a chronic pain inflammatory biomarker. Higher levels of serum cortisol may indicate greater chronic pain symptoms.
Time frame: baseline, 3 weeks, 6 weeks
Other Pre-specified
Change in Serum C-reactive Protein
The investigators will collect blood samples at each time frame and test for serum c-reactive protein, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.
Time frame: baseline, 3 weeks, 6 weeks
Other Pre-specified
Change in Serum Cytokines
The investigators will collect blood samples at each time frame and test for serum cytokines, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.
Time frame: baseline, 3 weeks, 6 weeks
Other Pre-specified
Change in Stress
Change in stress was assessed using the National Institutes of Health (NIH) Perceived Stress Scale (PSS-10) which consists of 10 items asking participants to assess the frequency of onset of stress-related symptoms over the prior month on a 5-item Likert scale ranging from 0-4. Six of the ten items are coded such that Never = 0 and Very often = 4; and four of the ten items are reverse-coded such that Never =4 and Very often = 0, for an overall scoring range of 0-40. The higher the score the worse the perceived stress. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of stress relative to baseline and negative mean scores were associated with reduced frequency of stress relative to baseline. Scores were summarized by study arm using basic descriptive statistics.
Time frame: From baseline to 6 weeks
Population: 3-week Stress (NIH Perceived Stress Scale) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RelieVRx | Change in Stress | -4.13 score on a scale | Standard Deviation 8.13 |
| Sham Virtual Reality | Change in Stress | 4.17 score on a scale | Standard Deviation 15.7 |
Comparison: We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.p-value: 0.13795% CI: [-23.1, 3.6]Regression, Linear