The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain

Study Overview
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Brief Summary
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Aim 1: To conduct a formative evaluation of museum-based programming to address loneliness and social isolation. Aim 2: To develop a consensus-derived Model Museum-Based Program (MMBP) to address loneliness among individuals with chronic pain. Aim 3: To evaluate the feasibility of museum experiences to reduce loneliness and pain among isolated individuals with chronic pain. Due to safety concerns related to the covid pandemic in-person museum programming could not continue and virtual versions of the interventions were created. We will publish results on both the in-person and virtual versions of the intervention as well as a pooled analysis.

Official Title
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The Analgesic Museum: The Development and Effectiveness of Museum-Based Experiences to Reduce Social Isolation and Pain Among Individuals With Chronic Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Usual care/wait list
* Behavioral: Art Rx
* Behavioral: Artful Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older English speaking Chronic pain (6 months or longer) Moderate pain or greater (4/10 or greater on a Numerical Rating Scale, range of 0 (no pain) - 10 (worst pain imaginable), in response to the question Over the past week what was your average pain intensity?) Moderately lonely or greater (Score of 4 or greater on 3 item Loneliness scale, range of 3 - 9) Exclusion Criteria: Participated in an Art Rx tour Participated in an Artful Meditation program Dementia or Alzheimer's disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Due to covid the in-person RCT was suspended and transitioned to virtual museum programming. Twenty-seven individuals were randomized into the in-person study and 122 individuals were randomized into the virtual study for a total of 149 enrolled individuals.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care/wait list<br> | Behavioral: Usual care/wait list<br>* Individuals in this group can continue with their usual care (but receive no museum-based intervention)<br>|
| Experimental: Art Rx<br> | Behavioral: Art Rx<br>* Individuals in this group participate in a specialized tour of an art museum<br>|
| Experimental: Artful Meditation<br> | Behavioral: Artful Meditation<br>* Individuals in this group participate in a meditation and art appreciation program at an art museum<br>|
| Experimental: Art Rx + Artful Meditation<br> | Behavioral: Art Rx<br>* Individuals in this group participate in a specialized tour of an art museum<br>Behavioral: Artful Meditation<br>* Individuals in this group participate in a meditation and art appreciation program at an art museum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program satisfaction - quality: NRS | Please rate your satisfaction with the overall quality of your experience at the museum? NRS - 0 (extremely dissatisfied) - 10 (extremely satisfied) | Post-intervention (immediately) | 
| Primary clinical outcome for preliminary estimate of efficacy - Social disconnection | Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60 | Post-intervention (immediately) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain during intervention: 1=Yes/0=No | Did you experience any pain relief during the museum experience? 1=Yes/0=No | Post-intervention (immediately) | 
| Percent change in pain during intervention | If Yes, what percent pain relief did you receive? 0%-100% | Post-intervention (immediately) | 
| Social disconnection | Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60 | Post-intervention (immediately) | 
| Pain unpleasantness | Numerical rating scale (NRS) score of 0 not unpleasant - 10 Most unpleasant sensation imaginable (intolerable) | Post-intervention (immediately) | 
| Pain unpleasantness | Numerical rating scale (NRS) score of 0 not unpleasant - 10 Most unpleasant sensation imaginable (intolerable) | Post-intervention (3-month follow up) | 
| Pain intensity: Numerical rating scale (NRS) score | Numerical rating scale (NRS) score of 0 no pain - 10 worst pain imaginable | Post-intervention (immediately) | 
| Pain intensity: Numerical rating scale (NRS) score | Numerical rating scale (NRS) score of 0 no pain - 10 worst pain imaginable | Post-intervention (3-month follow up) | 
| Pain interference | PEG scale - a 3 item scale to assess average pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G]. Item 1: What number best describes your pain on the average in the last week? Numerical rating scale (NRS) score of 0 no pain - 10 worst pain imaginable Item 2: What number best describes how, during the past week, pain has interfered with your enjoyment of life? Numerical rating scale (NRS) score of 0 does not interfere - 10 completely interferes Item 3: What number best describes how, during the past week, pain has interfered with your general activity? Numerical rating scale (NRS) score of 0 does not interfere - 10 completely interferes | Post-intervention (3-month follow up) | 
| Pain Catastrophizing Scale (PCS) | The PCS is a 13 item scale, with each item rated on a 5-point scale between: 0 (Not at all) and 4 (all the time). The PCS is broken into three subscales including: magnification, rumination, and helplessness. The total range of scores is between 0-52 with higher values reflecting more salient impacts of pain on one's day to day experience. | Post-intervention (3-month follow up) | 
| Chronic Pain Acceptance Questionnaire 8 (CPAQ-8) | 8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true) | Post-intervention (immediately) | 
| Chronic Pain Acceptance Questionnaire 8 (CPAQ-8) | 8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true) | Post-intervention (3-month follow up) | 
| PHQ 4 | 4 item scale to measure psychological distress (2 items depression; 2 items anxiety) Likert scale 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day) | Post-intervention (3-month follow up) | 
| Program satisfaction - recommend: NRS | How likely would you be to recommend this program to someone with a similar condition? NRS - 0 (extremely likely) - 10 (extremely unlikely) | Post-intervention (immediately) | 
| Affinity for art | Participants respond to the following prompt: I like art Likert scale: 0 (not at all) - 5 (very much) | Post-intervention (immediately) | 
| Affinity for art | Participants respond to the following prompt: I like art Likert scale: 0 (not at all) - 5 (very much) | Post-intervention (3-month follow up) |