Virtual Intelligence for Transformative Lifestyle Solutions in Pain

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 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 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 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.

Satisfaction will be measured and assessed using the Patient's Global Impression of Change Scale (PGIC) questionnaire completed following the VR intervention. Participants will be asked to respond to the following query, "Since beginning treatment at this clinic, how would you describe the change (if any) in Activity, Limitations, Symptoms, Emotions and Overall Quality of Life, related to your painful condition? (tick only 1 box)" on a 7-point Likert scale ranging from 1 - "No change (or condition is worse)" to 7 "A great deal better, and a considerable improvement that has made all the difference" such that higher scores are associated with improved global impression of change. Results will be summarized using basic descriptive statistics.

Satisfaction will be also measured and assessed using the following question derived from the PGIC questionnaire: "In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic." Participants will be asked to rate the degree of change on an 11-point scale ranging from 0 ("Much better") to 10 ("Much worse") such that lower scores are associated with a worsened degree of change. Results will be summarized using basic descriptive statistics.

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.

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.

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.

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.

Change in mood will be assessed using the Brief Mood Introspection Scale administered pre- and post-VR session. Participants are provided with 16 items and asked to circle the adjective/phrase that best describes present mood based on a 4-point scale (XX = "definitely do not feel"; X = "do not feel"; V = "slightly feel"; VV = "definitely feel"). Responses are converted to values (XX = 1, X = 2, V = 3, VV = 4 for positive items, and reversed for negative items). The 8 positive items are summed, and the 8 negative items are reverse-scored and summed. All 16 items are then summed yielding an overall possible range of 16-64 such that higher scores are indicative of a more pleasant mood. For purposes of this study change in mood from pre- to post-VR session will be assessed and positive scores will be associated with a more pleasant mood from pre- to post-intervention. Results will be summarized using descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Change in mindfulness will be assessed using a version of the State Mindfulness Scale (SMS) which will be administered prior to and following the VR session. The SMS consists of 21 items that assess mindfulness of mind (15 items) and body (6 items) over the last 15 minutes. Participants will be asked to rate each of the 21 items using a 5-point Likert scale ranging from 1 ("not at all") to 5 ("very well"), yielding an overall possible range of 21-105. Higher scores are associated with a greater current state of mindfulness. For purposes of this study change in mindfulness from pre- to post-VR session will be assessed and negative scores will be associated with decreased state of mindfulness/awareness of body and mind from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Self-efficacy in managing Drug/Opioid use and cravings will be evaluated using Opioid Medication Craving Scale administered prior to and following the VR session. The Opioid Medication Craving Scale consists of 3 items that assess the participants desire, likelihood and urges to use opioids. Participants are asked to rate each of the 3 items using on a scale from 0 ("No Desire" or "No likelihood of use") to 100 ("Strong Desire" or "Strong likelihood of Use"), yielding an overall scoring range of 0-300, such that higher scores are indicative of more intense opioid cravings. For purposes of this study change in self-efficacy from pre- to post-VR session will be assessed and negative scores will be associated with increased self-efficacy from pre- to post-intervention. Results will be summarized using basic descriptive statistics and analyzed by paired t-tests or Wilcoxon signed-rank tests.

Safety will be assessed using the VRSQ. The VRSQ outlines 9 symptoms (General discomfort, Fatigue, Headache, Eye strain, Difficulty focusing, Fullness of the Head, Blurred vision, Dizziness with eyes closed, and Vertigo) and asks participants to rate how much each symptom is affecting them at the time of the study as follows: 0 = None, 1 = Slight, 2 = Moderate, 3 = Severe. Scoring is determined by summing the score of the first four symptoms on the list (=A); summing the score of the last 5 symptoms on the list (=B); calculating the variable "C" in C = A/12 x 100; and calculating the variable "D" in D = B/15 x100. Finally, A VRSQ score is determined by the following formula: VRSQ = (C+D)/2. Higher VRSQ scores are indicative of greater levels of VR sickness. Results will be summarized by study arm using basic descriptive statistics.