Chronic PainNCT04091893
The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain
A study testing Art Rx and Artful Meditation in people with Chronic Pain, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Art Rx and Artful Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2019to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Participated in an Art Rx tour
- Participated in an Artful Meditation program
- Dementia or Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Ambulatory Care Center
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Usual care/wait list, Art Rx, Artful Meditation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care/wait listBehavioural
Individuals in this group can continue with their usual care (but receive no museum-based intervention)
Art RxBehavioural
Individuals in this group participate in a specialized tour of an art museum
Artful MeditationBehavioural
Individuals in this group participate in a meditation and art appreciation program at an art museum
| Study group | Role | What they receive |
|---|---|---|
| Usual care/wait list | Active comparator | Not described Receives: Behavioral: Usual care/wait list |
| Art Rx | Experimental | Not described Receives: Behavioral: Art Rx |
| Artful Meditation | Experimental | Not described Receives: Behavioral: Artful Meditation |
| Art Rx + Artful Meditation | Experimental | Not described Receives: Behavioral: Art Rx; Behavioral: Artful Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post-intervention (immediately)
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
Measured: Post-intervention (immediately)
Secondary outcomes (15)
Change in pain during intervention: 1=Yes/0=No
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Measured: Post-intervention (immediately)
Percent change in pain during intervention
If "Yes", what percent pain relief did you receive? 0%-100%
Measured: Post-intervention (immediately)
Social disconnection
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Measured: Post-intervention (immediately)
Pain unpleasantness
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Measured: Post-intervention (immediately)
Pain unpleasantness
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Measured: Post-intervention (3-month follow up)
Pain intensity: Numerical rating scale (NRS) score
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Measured: Post-intervention (immediately)
Pain intensity: Numerical rating scale (NRS) score
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Measured: Post-intervention (3-month follow up)
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"
Measured: Post-intervention (3-month follow up)
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.
Measured: Post-intervention (3-month follow up)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
8 items scale designed to measure acceptance of pain.
Likert scale 0 (never true) - 6 (always true)
Measured: Post-intervention (immediately)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true)
Measured: Post-intervention (3-month follow up)
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)
Measured: Post-intervention (3-month follow up)
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)
Measured: Post-intervention (immediately)
Affinity for art
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Measured: Post-intervention (immediately)
Affinity for art
Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)
Measured: Post-intervention (3-month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start12 Oct 2019
- Primary completion15 Feb 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091893
- Sponsor's protocol ID
- 1415639
- Status last verified
- Dec 2021
- First submitted
- 6 Sep 2019
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Museum: The Development and Effectiveness of Museum-Based Experiences to Reduce Social Isolation and Pain Among Individuals With Chronic Pain
- ClinicalTrials.gov ID
- NCT04091893
- Acronym / sponsor ID
- 1415639
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care/wait list | Active comparator | Behavioral: Usual care/wait list |
| Art Rx | Experimental | Behavioral: Art Rx |
| Artful Meditation | Experimental | Behavioral: Artful Meditation |
| Art Rx + Artful Meditation | Experimental | Behavioral: Art Rx, Behavioral: Artful Meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Participated in an Art Rx tour
- Participated in an Artful Meditation program
- Dementia or Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care/wait listIndividuals in this group can continue with their usual care (but receive no museum-based intervention) | Behavioural | Usual care/wait list |
| Art RxIndividuals in this group participate in a specialized tour of an art museum | Behavioural | Art Rx, Art Rx + Artful Meditation |
| Artful MeditationIndividuals in this group participate in a meditation and art appreciation program at an art museum | Behavioural | Art Rx + Artful Meditation, Artful Meditation |
Primary outcome
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)
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
15 secondary outcomes
Change in pain during intervention: 1=Yes/0=No
Time frame: Post-intervention (immediately)
Percent change in pain during intervention
Time frame: Post-intervention (immediately)
Social disconnection
Time frame: Post-intervention (immediately)
Pain unpleasantness
Time frame: Post-intervention (immediately)
Pain unpleasantness
Time frame: Post-intervention (3-month follow up)
Pain intensity: Numerical rating scale (NRS) score
Time frame: Post-intervention (immediately)
Pain intensity: Numerical rating scale (NRS) score
Time frame: Post-intervention (3-month follow up)
Pain interference
Time frame: Post-intervention (3-month follow up)
Pain Catastrophizing Scale (PCS)
Time frame: Post-intervention (3-month follow up)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
Time frame: Post-intervention (immediately)
Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
Time frame: Post-intervention (3-month follow up)
PHQ 4
Time frame: Post-intervention (3-month follow up)
Program satisfaction - recommend: NRS
Time frame: Post-intervention (immediately)
Affinity for art
Time frame: Post-intervention (immediately)
Affinity for art
Time frame: Post-intervention (3-month follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Rx and Artful Meditation in people with Chronic Pain, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program satisfaction - quality: NRS (time frame: Post-intervention (immediately)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021; AzTrials last refreshed its copy on 2 Nov 2026.