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临床试验/NCT04091893
NCT04091893已完成不适用

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

University of California, Davis1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2019年10月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
Program satisfaction - quality: NRS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •Participated in an Art Rx tour
  • •Participated in an Artful Meditation program
  • •Dementia or Alzheimer's disease

研究组 & 干预措施

Usual care/wait list

Active Comparator

干预措施: Usual care/wait list (Behavioral)

Art Rx

Experimental

干预措施: Art Rx (Behavioral)

Artful Meditation

Experimental

干预措施: Artful Meditation (Behavioral)

Art Rx + Artful Meditation

Experimental

干预措施: Art Rx (Behavioral)

Art Rx + Artful Meditation

Experimental

干预措施: Artful Meditation (Behavioral)

结局指标

主要结局

Program satisfaction - quality: NRS

时间窗: 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

时间窗: Post-intervention (immediately)

Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60

次要结局

  • Social disconnection(Post-intervention (immediately))
  • Pain unpleasantness(Post-intervention (3-month follow up))
  • PHQ 4(Post-intervention (3-month follow up))
  • Affinity for art(Post-intervention (3-month follow up))
  • Pain intensity: Numerical rating scale (NRS) score(Post-intervention (3-month follow up))
  • Program satisfaction - recommend: NRS(Post-intervention (immediately))
  • Pain Catastrophizing Scale (PCS)(Post-intervention (3-month follow up))
  • Change in pain during intervention: 1=Yes/0=No(Post-intervention (immediately))
  • Percent change in pain during intervention(Post-intervention (immediately))
  • Pain interference(Post-intervention (3-month follow up))
  • Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)(Post-intervention (3-month follow up))
  • Pain unpleasantness(Post-intervention (immediately))
  • Pain intensity: Numerical rating scale (NRS) score(Post-intervention (immediately))
  • Chronic Pain Acceptance Questionnaire 8 (CPAQ-8)(Post-intervention (immediately))
  • Affinity for art(Post-intervention (immediately))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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