Trial Outcomes & Findings for Virtual Reality for Pain in Acute Orthopedic Injuries (NCT NCT05552430)

NCT ID: NCT05552430

Last Updated: 2024-08-22

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Pre-intervention (week 0) only
• Results posted on: 2024-08-22

Participant Flow

No enrolled participants were excluded from the study.

Participant milestones

Measure	Skills-Based VR 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality for Pain in Acute Orthopedic Injuries

Baseline characteristics by cohort

Measure	Skills-Based VR n=10 Participants 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. RelieveVRx: 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.
Age, Continuous	46.8 years STANDARD_DEVIATION 11.86 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Marital Status Married	3 Participants n=5 Participants
Marital Status Single, never married	5 Participants n=5 Participants
Marital Status Separated or Divorced	1 Participants n=5 Participants
Marital Status Widowed	1 Participants n=5 Participants
Education Some college/Associates degree (<16 years)	1 Participants n=5 Participants
Education Completed college (16 years)	3 Participants n=5 Participants
Education Graduate/professional degree (>16 years)	6 Participants n=5 Participants
Employment Employed full-time	8 Participants n=5 Participants
Employment Employed part-time	1 Participants n=5 Participants
Employment Unemployed	1 Participants n=5 Participants
Income $15,000 to less than $20,000	1 Participants n=5 Participants
Income $50,000 to less than $75,000	3 Participants n=5 Participants
Income $75,000 or more	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale

8 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale

9 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Client Satisfaction Questionnaire

9 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

System Usability Scale

8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Patient's Global Impression of Change

10 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Motion Sickness and Nausea

10 Participants

SECONDARY outcome

Timeframe: Throughout the study completion, approximately 1 year

Population: This benchmark indicates the number of participants enrolled out of total eligible. More participants were deemed eligible than the number that enrolled, ultimately making the overall number of participants greater than the number stated in the participant flow.

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).

Outcome measures

Measure

Skills-Based VR n=12 Participants 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.

Feasibility of Enrollment

10 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Acceptability of Treatment

10 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Adherence to Pain Surveys

8 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Skills-Based VR n=10 Participants 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.

Feasibility of Outcome Assessments

10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-intervention (week 0), Post-intervention (week 8)

Population: Out of 10 total participants, only 6 were included in the analysis for the Outcome Measure as they were taking non-narcotic medications during the study.

Number of days that non-narcotic pain medications were taken in the last week.

Outcome measures

Measure	Skills-Based VR n=6 Participants 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.
Non-narcotic Pain Medications Pre-intervention	1.9 days per week Standard Deviation 2.23
Non-narcotic Pain Medications Post-intervention	0.6 days per week Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Pre-intervention	57.86 T-score Standard Deviation 7.94
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Post-intervention	47.27 T-score Standard Deviation 9.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Pre-intervention	35.32 T-score Standard Deviation 6.86
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Post-intervention	43.26 T-score Standard Deviation 7.13

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index Pre-intervention	51.93 Standardized subscale score Standard Deviation 8.45
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index Post-intervention	35.46 Standardized subscale score Standard Deviation 7.59

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index Pre-intervention	60.76 Standardized subscale score Standard Deviation 10.61
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index Post-intervention	38.17 Standardized subscale score Standard Deviation 11.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Numerical Rating Scale (NRS) - Pain at Rest Pre-intervention	3.50 score on a scale Standard Deviation 1.27
Numerical Rating Scale (NRS) - Pain at Rest Post-intervention	1.00 score on a scale Standard Deviation 0.94

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Numerical Rating Scale (NRS) - Pain With Activity Pre-intervention	6.30 score on a scale Standard Deviation 1.64
Numerical Rating Scale (NRS) - Pain With Activity Post-intervention	2.90 score on a scale Standard Deviation 1.79

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Pain Catastrophizing Scale (PCS) Pre-intervention	23.90 score on a scale Standard Deviation 9.62
Pain Catastrophizing Scale (PCS) Post-intervention	7.50 score on a scale Standard Deviation 5.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Pain Anxiety Scale (PASS) Pre-intervention	51.10 score on a scale Standard Deviation 17.40
Pain Anxiety Scale (PASS) Post-intervention	18.40 score on a scale Standard Deviation 12.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Pain Self-Efficacy Questionnaire (PSEQ) Pre-intervention	35.50 score on a scale Standard Deviation 12.67
Pain Self-Efficacy Questionnaire (PSEQ) Post-intervention	50.90 score on a scale Standard Deviation 6.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Center for Epidemiologic Study of Depression (CESD) Scale Pre-intervention	20.00 score on a scale Standard Deviation 8.63
Center for Epidemiologic Study of Depression (CESD) Scale Post-intervention	10.90 score on a scale Standard Deviation 6.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Cognitive and Affective Mindfulness Scale (CAMS) Pre-intervention	31.20 score on a scale Standard Deviation 3.88
Cognitive and Affective Mindfulness Scale (CAMS) Post-intervention	35.90 score on a scale Standard Deviation 5.92

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale Pre-intervention	6.90 score on a scale Standard Deviation 2.56
Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale Post-intervention	2.00 score on a scale Standard Deviation 2.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale Pre-intervention	5.90 score on a scale Standard Deviation 3.41
Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale Post-intervention	1.80 score on a scale Standard Deviation 2.74

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale Pre-intervention	6.00 score on a scale Standard Deviation 1.83
Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale Post-intervention	2.10 score on a scale Standard Deviation 1.79

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale Pre-intervention	6.40 score on a scale Standard Deviation 1.51
Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale Post-intervention	2.20 score on a scale Standard Deviation 2.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Skills-Based VR n=10 Participants 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.
Measure of Current Status (MOCS) Pre-intervention	2.19 score on a scale Standard Deviation 0.53
Measure of Current Status (MOCS) Post-intervention	2.78 score on a scale Standard Deviation 0.64

Adverse Events

Skills-Based VR

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure

Skills-Based VR n=10 participants at risk 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.

Infections and infestations Brief, unrelated hospitalization

10.0% 1/10 • Number of events 1 • Adverse event data were collected between baseline (Week 0) and post-test assessments (Week 9).

Other adverse events

Measure	Skills-Based VR n=10 participants at risk 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.
Psychiatric disorders Mild, related event due to "scuba" module	10.0% 1/10 • Number of events 1 • Adverse event data were collected between baseline (Week 0) and post-test assessments (Week 9).
Psychiatric disorders fNIRS Movement	10.0% 1/10 • Number of events 1 • Adverse event data were collected between baseline (Week 0) and post-test assessments (Week 9).

Additional Information

Dr. Ryan Mace

Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital

Phone: 617-724-7030

Email: rmace@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place