Clinical Trial Radar

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.

Approximately 6 months

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.

Approximately 6 months

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.

Up to 1 hour following completion of ~ 45-minute VR session

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.

Up to 1 hour following completion of ~ 45-minute VR session

Satisfaction - Change

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.

Up to 1 hour following completion of ~ 45-minute VR session

Satisfaction - Degree of Change

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.

Up to 1 hour following completion of ~ 45-minute VR session

Efficacy - Change in Pain Severity Level

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.

From pre- to post-VR session, up to 4 hours

Efficacy - Change in Anxiety Level

Change in anxiety will be assessed using the Pain Anxiety Symptom Scale Short Form 20 (PASS-20) administered prior to and following the VR session. The PASS-20 is a 20-item questionnaire that assesses pain-related anxiety. Participants will be asked to rate each of the 20 items on the questionnaire in terms of frequency on a 6-point Likert scale ranging from 0 ("Never") to 5 ("Always"). Higher PASS-20 scores are associated with greater pain-related anxiety. 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 pain-related 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.

From pre- to post-VR session, up to 4 hours

Efficacy - Self-efficacy in managing Drug/Opioid use and cravings

Self-efficacy in managing Drug/Opioid use and cravings will be evaluated using the Drug Abstinence Self-Efficacy Scale (DASES) administered prior to and following the VR session. DASES describes 16 situations that may trigger someone's intention to take drugs and asks participants to select a response indicating what they would be likely to do in each situation. Participants are asked to rate each of the 16 situations using a 7-point scale ranging from 1 ("Certainly no") to 7 ("Certainly yes") such that higher scores are indicative of an individual having more confidence in their ability to resist drug use in specific situations. For purposes of this study change in self-efficacy from pre- to post-VR session will be assessed and positive 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.

From pre- to post-VR session, up to 4 hours

Safety - Virtual Reality Sickness Questionnaire (VRSQ)

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.

Up to 1 hour following completion of ~ 45-minute VR session