Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT05552430
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education.
Time frame: Pre-intervention (week 0) only
Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Pre-intervention (week 0) only
Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
The number of participants that improved "much or very much" or "minimally" on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program.
Time frame: Post-intervention (week 8) only
Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Throughout the study completion, approximately 1 year
We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
Number of days that non-narcotic pain medications were taken in the last week.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills.
Massachusetts General Hospital
Other
Physical and Psychological Measures of Pain in Acute Orthopedic Injuries: Use of At-home Virtual Reality
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