Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-11 @ 8:59 AM
Study NCT ID:
NCT04091893
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2019-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program satisfaction - quality: NRS', 'timeFrame': 'Post-intervention (immediately)', 'description': '"Please rate your satisfaction with the overall quality of your experience at the museum?"\n\nNRS - 0 (extremely dissatisfied) - 10 (extremely satisfied)'}, {'measure': 'Primary clinical outcome for preliminary estimate of efficacy - Social disconnection', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60'}], 'secondaryOutcomes': [{'measure': 'Change in pain during intervention: 1=Yes/0=No', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Did you experience any pain relief during the museum experience? 1=Yes/0=No'}, {'measure': 'Percent change in pain during intervention', 'timeFrame': 'Post-intervention (immediately)', 'description': 'If "Yes", what percent pain relief did you receive? 0%-100%'}, {'measure': 'Social disconnection', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60'}, {'measure': 'Pain unpleasantness', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"'}, {'measure': 'Pain unpleasantness', 'timeFrame': 'Post-intervention (3-month follow up)', 'description': 'Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"'}, {'measure': 'Pain intensity: Numerical rating scale (NRS) score', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"'}, {'measure': 'Pain intensity: Numerical rating scale (NRS) score', 'timeFrame': 'Post-intervention (3-month follow up)', 'description': 'Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"'}, {'measure': 'Pain interference', 'timeFrame': 'Post-intervention (3-month follow up)', '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\\].\n\nItem 1: What number best describes your pain on the average in the last week?\n\nNumerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"\n\nItem 2: What number best describes how, during the past week, pain has interfered with your enjoyment of life?\n\nNumerical rating scale (NRS) score of 0 "does not interfere" - 10 "completely interferes"\n\nItem 3: What number best describes how, during the past week, pain has interfered with your general activity?\n\nNumerical rating scale (NRS) score of 0 "does not interfere" - 10 "completely interferes"'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Post-intervention (3-month follow up)', '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."}, {'measure': 'Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)', 'timeFrame': 'Post-intervention (immediately)', 'description': '8 items scale designed to measure acceptance of pain.\n\nLikert scale 0 (never true) - 6 (always true)'}, {'measure': 'Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)', 'timeFrame': 'Post-intervention (3-month follow up)', 'description': '8 items scale designed to measure acceptance of pain. Likert scale 0 (never true) - 6 (always true)'}, {'measure': 'PHQ 4', 'timeFrame': 'Post-intervention (3-month follow up)', '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)'}, {'measure': 'Program satisfaction - recommend: NRS', 'timeFrame': 'Post-intervention (immediately)', 'description': 'How likely would you be to recommend this program to someone with a similar condition? NRS - 0 (extremely likely) - 10 (extremely unlikely)'}, {'measure': 'Affinity for art', 'timeFrame': 'Post-intervention (immediately)', 'description': 'Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)'}, {'measure': 'Affinity for art', 'timeFrame': 'Post-intervention (3-month follow up)', 'description': 'Participants respond to the following prompt: "I like art" Likert scale: 0 (not at all) - 5 (very much)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Aim 1: To conduct a formative evaluation of museum-based programming to address loneliness and social isolation.\n\nAim 2: To develop a consensus-derived Model Museum-Based Program (MMBP) to address loneliness among individuals with chronic pain.\n\nAim 3: To evaluate the feasibility of museum experiences to reduce loneliness and pain among isolated individuals with chronic pain.\n\nDue 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* English speaking\n* Chronic pain (6 months or longer)\n* 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?")\n* Moderately lonely or greater (Score of 4 or greater on 3 item Loneliness scale, range of 3 - 9)\n\nExclusion Criteria:\n\n* Participated in an Art Rx tour\n* Participated in an Artful Meditation program\n* Dementia or Alzheimer\'s disease'}, 'identificationModule': {'nctId': 'NCT04091893', 'briefTitle': 'The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Analgesic Museum: The Development and Effectiveness of Museum-Based Experiences to Reduce Social Isolation and Pain Among Individuals With Chronic Pain', 'orgStudyIdInfo': {'id': '1415639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care/wait list', 'interventionNames': ['Behavioral: Usual care/wait list']}, {'type': 'EXPERIMENTAL', 'label': 'Art Rx', 'interventionNames': ['Behavioral: Art Rx']}, {'type': 'EXPERIMENTAL', 'label': 'Artful Meditation', 'interventionNames': ['Behavioral: Artful Meditation']}, {'type': 'EXPERIMENTAL', 'label': 'Art Rx + Artful Meditation', 'interventionNames': ['Behavioral: Art Rx', 'Behavioral: Artful Meditation']}], 'interventions': [{'name': 'Usual care/wait list', 'type': 'BEHAVIORAL', 'description': 'Individuals in this group can continue with their usual care (but receive no museum-based intervention)', 'armGroupLabels': ['Usual care/wait list']}, {'name': 'Art Rx', 'type': 'BEHAVIORAL', 'description': 'Individuals in this group participate in a specialized tour of an art museum', 'armGroupLabels': ['Art Rx', 'Art Rx + Artful Meditation']}, {'name': 'Artful Meditation', 'type': 'BEHAVIORAL', 'description': 'Individuals in this group participate in a meditation and art appreciation program at an art museum', 'armGroupLabels': ['Art Rx + Artful Meditation', 'Artful Meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Ambulatory Care Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}