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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091893
• Other study ID #: 1415639
• Status: Completed
• Phase: N/A
• Start date: October 12, 2019
• Est. completion date: March 10, 2021

Study information

• Verified date: December 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 10, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Usual care/wait list
Individuals in this group can continue with their usual care (but receive no museum-based intervention)
• Art Rx
Individuals in this group participate in a specialized tour of an art museum
• Artful Meditation
Individuals in this group participate in a meditation and art appreciation program at an art museum

Locations

Country	Name	City	State
United States	UC Davis Ambulatory Care Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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)
Secondary	Percent change in pain during intervention	If "Yes", what percent pain relief did you receive? 0%-100%	Post-intervention (immediately)
Secondary	Social disconnection	Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60	Post-intervention (immediately)
Secondary	Pain unpleasantness	Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"	Post-intervention (immediately)
Secondary	Pain unpleasantness	Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"	Post-intervention (3-month follow up)
Secondary	Pain intensity: Numerical rating scale (NRS) score	Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"	Post-intervention (immediately)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Affinity for art	Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)	Post-intervention (immediately)
Secondary	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)