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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, Davis2 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

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
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

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

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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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