Clinical trial NCT04091893: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Program satisfaction - quality: NRS
timeFrame: Post-intervention (immediately)
measure: Primary clinical outcome for preliminary estimate of efficacy - Social disconnection
timeFrame: Post-intervention (immediately)
Secondary outcomes:
measure: Change in pain during intervention: 1=Yes/0=No
timeFrame: Post-intervention (immediately)
measure: Percent change in pain during intervention
timeFrame: Post-intervention (immediately)
measure: Social disconnection
timeFrame: Post-intervention (immediately)
measure: Pain unpleasantness
timeFrame: Post-intervention (immediately)
measure: Pain unpleasantness
timeFrame: Post-intervention (3-month follow up)
measure: Pain intensity: Numerical rating scale (NRS) score
timeFrame: Post-intervention (immediately)
measure: Pain intensity: Numerical rating scale (NRS) score
timeFrame: Post-intervention (3-month follow up)
measure: Pain interference
timeFrame: Post-intervention (3-month follow up)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Post-intervention (3-month follow up)
measure: Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
timeFrame: Post-intervention (immediately)
measure: Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)
timeFrame: Post-intervention (3-month follow up)
measure: PHQ 4
timeFrame: Post-intervention (3-month follow up)
measure: Program satisfaction - recommend: NRS
timeFrame: Post-intervention (immediately)
measure: Affinity for art
timeFrame: Post-intervention (immediately)
measure: Affinity for art
timeFrame: Post-intervention (3-month follow up)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Ambulatory Care Center
state: California
Study officials:
References: