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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Art Rx; Behavioral: Usual care/wait list; Behavioral: Artful Meditation

• Registration Number: NCT04091893
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Study Start: 2019-10-12
• Primary Completion: 2021-02-15
• Study Completion: 2021-03-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Art Rx + Artful Meditation	Art Rx	-
Art Rx + Artful Meditation	Artful Meditation	-
Usual care/wait list	Usual care/wait list	-
Art Rx	Art Rx	-
Artful Meditation	Artful Meditation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Social disconnection	Post-intervention (immediately)	Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Pain unpleasantness	Post-intervention (3-month follow up)	Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
PHQ 4	Post-intervention (3-month follow up)	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)
Affinity for art	Post-intervention (3-month follow up)	Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Pain intensity: Numerical rating scale (NRS) score	Post-intervention (3-month follow up)	Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Program satisfaction - recommend: NRS	Post-intervention (immediately)	How likely would you be to recommend this program to someone with a similar condition? NRS - 0 (extremely likely) - 10 (extremely unlikely)
Pain Catastrophizing Scale (PCS)	Post-intervention (3-month follow up)	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.
Change in pain during intervention: 1=Yes/0=No	Post-intervention (immediately)	Did you experience any pain relief during the museum experience? 1=Yes/0=No
Percent change in pain during intervention	Post-intervention (immediately)	If "Yes", what percent pain relief did you receive? 0%-100%
Pain interference	Post-intervention (3-month follow up)	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"
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)	Post-intervention (3-month follow up)	8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true)

Trial Locations

Locations (1)

UC Davis Ambulatory Care Center; 🇺🇸 Sacramento, California, United States