Virtual Intelligence for Transformative Lifestyle Solutions in Pain

Feasibility - Recruitment Rate

Feasibility of the intervention will be assessed by tracking and determining the recruitment rate for the study. For purposes of this study recruitment rate will be defined as the number/percentage of participants who are consented, screened, and enrolled over the 6-month timeframe will be summarized and reported.

Feasibility - Completion

Feasibility of the intervention will also be assessed by the number/percentage of participants who are able to successfully complete all three AI-guided, VR sessions. The number/percentage of participants that complete all three sessions will be summarized and reported using basic descriptive statistics.

Feasibility - Virtual Reality Experience and Feasibility Survey (VREFS)

Feasibility of the intervention as assessed by VREFS will also be determined. The VREFS is a comprehensive feasibility tool which measures feasibility across 7 distinct dimensions: Core Therapeutic Alliance (6 items); Cultural Competence \& Identity (5 items); Continuity \& Future Use (3 items); Privacy \& Trust (8 items); Medical Trust (3 items); Usability (11 items); and Overall Experience (6 items). The survey also consists of 4 additional items and 6 avatar-specific items. Participants are asked to evaluate and rate each statement on a 7-point scale ranging from 1 ("Strongly disagree") to 7 ("Strongly agree") such that higher scores are associated with a more favorable assessment of the intervention and study. Results will be summarized and reported using basic descriptive statistics.

Acceptability - Acceptability of Intervention Measure (AIM)

Acceptability of the intervention will be evaluated using AIM. AIM consists of 4 statements which asks participants to rate the acceptability of the intervention measures on a 5-point scale ranging from 1 ("Completely disagree") to 5 ("Completely agree") for an overall possible scoring range of 4-20, with higher scores being indicative of greater acceptability of the measures. Results will be summarized using basic descriptive statistics.

Efficacy - Change in Pain Severity

Change in pain severity will be assessed based on the Visual Analog Scale (VAS) administered prior to and following the VR session. Participants will be asked to rate their average pain over the last 24 hours below by selecting a number that describes their pain level on an 11-point Likert scale ranging from 0 ("NO pain") to 10 (WORST imaginable pain"). Higher VAS scores are associated with greater pain intensity/severity. For purposes of this study change in pain severity from pre- to post-VR session will be assessed and negative scores will be associated with decreased pain severity from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Efficacy - Change in Avoidance Behavior

Avoidance Behavior will be assessed using the Pain Catastrophizing Questionnaire administered prior to and following the VR session. The Pain Catastrophizing Questionnaire consists of 6 items that assess the participants thoughts - rumination, magnification, and helplessness - regarding pain. Participants will be asked to rate each of the 6 items using a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("All the time"), yielding an overall possible range of 0-24. Higher scores are associated with greater pain-related catastrophic thinking. For purposes of this study change in avoidance behavior from pre- to post-VR session will be assessed and negative scores will be associated with decreased pain-related catastrophic thoughts from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Efficacy - Change in Anxiety

Change in anxiety will be assessed using a modified version of the PROMIS Version 1.0 -Anxiety 4a scale which will be administered prior to and following the VR session. This questionnaire consists of 5 items that assess pain-related anxiety. Participants will be asked to rate each of the 5 items in terms frequency of symptoms based on current status (today) using a 6-point Likert scale ranging from 0 ("Never") to 5 ("Always"), yielding an overall possible range of 0-25. Higher scores are associated with greater anxiety severity. For purposes of this study change in anxiety from pre- to post-VR session will be assessed and negative scores will be associated with decreased severity of anxiety from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Efficacy - Change in Mood/Depression

Change in mood/depression will be assessed using a modified version of the PROMIS Version 1.0 - Depression 4a scale which will be administered prior to and following the VR session. This questionnaire consists of 5 items that assess pain-related mood/depressive symptoms. Participants will be asked to rate each of the 5 items in terms frequency of symptoms based on current status (today) using a 6-point Likert scale ranging from 0 ("Never") to 5 ("Always"), yielding an overall possible range of 0-25. Higher scores are associated with greater severity of depression. For purposes of this study change in mood/depression from pre- to post-VR session will be assessed and negative scores will be associated with decreased severity of mood/depressive symptoms from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.