The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care/wait list
Art Rx
Artful Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility 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
Sites / Locations
- UC Davis Ambulatory Care Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Usual care/wait list
Art Rx
Artful Meditation
Art Rx + Artful Meditation
Arm Description
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
Change in pain during intervention: 1=Yes/0=No
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Percent change in pain during intervention
If "Yes", what percent pain relief did you receive? 0%-100%
Social disconnection
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Pain unpleasantness
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Pain unpleasantness
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Pain intensity: Numerical rating scale (NRS) score
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Pain intensity: Numerical rating scale (NRS) score
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
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"
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.
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
8 items scale designed to measure acceptance of pain.
Likert scale 0 (never true) - 6 (always true)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true)
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)
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)
Affinity for art
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Affinity for art
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Full Information
NCT ID
NCT04091893
First Posted
September 6, 2019
Last Updated
December 1, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04091893
Brief Title
The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain
Official Title
The Analgesic Museum: The Development and Effectiveness of Museum-Based Experiences to Reduce Social Isolation and Pain Among Individuals With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Due to covid the in-person RCT was suspended and transitioned to virtual museum programming. Twenty-seven individuals were randomized into the in-person study and 122 individuals were randomized into the virtual study for a total of 149 enrolled individuals.
Masking
Investigator
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care/wait list
Arm Type
Active Comparator
Arm Title
Art Rx
Arm Type
Experimental
Arm Title
Artful Meditation
Arm Type
Experimental
Arm Title
Art Rx + Artful Meditation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Usual care/wait list
Intervention Description
Individuals in this group can continue with their usual care (but receive no museum-based intervention)
Intervention Type
Behavioral
Intervention Name(s)
Art Rx
Intervention Description
Individuals in this group participate in a specialized tour of an art museum
Intervention Type
Behavioral
Intervention Name(s)
Artful Meditation
Intervention Description
Individuals in this group participate in a meditation and art appreciation program at an art museum
Primary Outcome Measure Information:
Title
Program satisfaction - quality: NRS
Description
"Please rate your satisfaction with the overall quality of your experience at the museum?"
NRS - 0 (extremely dissatisfied) - 10 (extremely satisfied)
Time Frame
Post-intervention (immediately)
Title
Primary clinical outcome for preliminary estimate of efficacy - Social disconnection
Description
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Time Frame
Post-intervention (immediately)
Secondary Outcome Measure Information:
Title
Change in pain during intervention: 1=Yes/0=No
Description
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Time Frame
Post-intervention (immediately)
Title
Percent change in pain during intervention
Description
If "Yes", what percent pain relief did you receive? 0%-100%
Time Frame
Post-intervention (immediately)
Title
Social disconnection
Description
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Time Frame
Post-intervention (immediately)
Title
Pain unpleasantness
Description
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Time Frame
Post-intervention (immediately)
Title
Pain unpleasantness
Description
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Time Frame
Post-intervention (3-month follow up)
Title
Pain intensity: Numerical rating scale (NRS) score
Description
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Time Frame
Post-intervention (immediately)
Title
Pain intensity: Numerical rating scale (NRS) score
Description
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Time Frame
Post-intervention (3-month follow up)
Title
Pain interference
Description
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"
Time Frame
Post-intervention (3-month follow up)
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Post-intervention (3-month follow up)
Title
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
Description
8 items scale designed to measure acceptance of pain.
Likert scale 0 (never true) - 6 (always true)
Time Frame
Post-intervention (immediately)
Title
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
Description
8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true)
Time Frame
Post-intervention (3-month follow up)
Title
PHQ 4
Description
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)
Time Frame
Post-intervention (3-month follow up)
Title
Program satisfaction - recommend: NRS
Description
How likely would you be to recommend this program to someone with a similar condition? NRS - 0 (extremely likely) - 10 (extremely unlikely)
Time Frame
Post-intervention (immediately)
Title
Affinity for art
Description
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Time Frame
Post-intervention (immediately)
Title
Affinity for art
Description
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Time Frame
Post-intervention (3-month follow up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
UC Davis Ambulatory Care Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain
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