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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091893
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Usual care/wait list Behavioral: Art Rx Behavioral: Artful Meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Analgesic Museum: The Development and Effectiveness of Museum-Based Experiences to Reduce Social Isolation and Pain Among Individuals With Chronic Pain
Actual Study Start Date : October 12, 2019
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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




Primary Outcome Measures :
  1. 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)


  2. 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


Secondary Outcome Measures :
  1. 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

  2. Percent change in pain during intervention [ Time Frame: Post-intervention (immediately) ]
    If "Yes", what percent pain relief did you receive? 0%-100%

  3. Social disconnection [ Time Frame: Post-intervention (3-month follow up) ]
    Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60

  4. Pain unpleasantness [ Time Frame: Post-intervention (immediately) ]
    Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"

  5. 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")"

  6. 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"

  7. 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"

  8. 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"


  9. 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.

  10. 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)


  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091893


Contacts
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Contact: Ian Koebner, PhD 9167346792 ikoebner@ucdavis.edu

Locations
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United States, California
UC Davis Ambulatory Care Center Recruiting
Sacramento, California, United States, 95817
Contact: Ian Koebner, PhD    916-734-6792    ikoebner@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04091893    
Other Study ID Numbers: 1415639
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms