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Completed

NCT Number: NCT04091893

The Development and Effectiveness of Museum-Based Experiences for 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Ambulatory Care Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual care/wait list

Behavioral

Individuals in this group can continue with their usual care (but receive no museum-based intervention)

Art Rx

Behavioral

Individuals in this group participate in a specialized tour of an art museum

Artful Meditation

Behavioral

Individuals in this group participate in a meditation and art appreciation program at an art museum

Primary outcomes

  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 outcomes

  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 (immediately)

    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)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2019
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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