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

December 1, 2021 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Ambulatory Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program satisfaction - quality: NRS
Time Frame: Post-intervention (immediately)

"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
Time Frame: Post-intervention (immediately)
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
Time Frame: Post-intervention (immediately)
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Post-intervention (immediately)
Percent change in pain during intervention
Time Frame: Post-intervention (immediately)
If "Yes", what percent pain relief did you receive? 0%-100%
Post-intervention (immediately)
Social disconnection
Time Frame: Post-intervention (immediately)
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Post-intervention (immediately)
Pain unpleasantness
Time Frame: Post-intervention (immediately)
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Post-intervention (immediately)
Pain unpleasantness
Time Frame: Post-intervention (3-month follow up)
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
Time Frame: Post-intervention (immediately)
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Post-intervention (immediately)
Pain intensity: Numerical rating scale (NRS) score
Time Frame: Post-intervention (3-month follow up)
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Post-intervention (3-month follow up)
Pain interference
Time Frame: 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"
Post-intervention (3-month follow up)
Pain Catastrophizing Scale (PCS)
Time Frame: 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.
Post-intervention (3-month follow up)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
Time Frame: Post-intervention (immediately)

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)
Time Frame: Post-intervention (3-month follow up)
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
Time Frame: 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)
Post-intervention (3-month follow up)
Program satisfaction - recommend: NRS
Time Frame: 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)
Post-intervention (immediately)
Affinity for art
Time Frame: Post-intervention (immediately)
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Post-intervention (immediately)
Affinity for art
Time Frame: Post-intervention (3-month follow up)
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Post-intervention (3-month follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2019

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

March 10, 2021

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1415639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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