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临床试验/NCT04349033
NCT04349033已完成不适用

Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure

Wayne State University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年2月10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
94
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.

详细描述

Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Chronic musculoskeletal Pain

排除标准

  • •Non-English speaking

研究组 & 干预措施

Emotional Disclosure and Brain Education

Experimental

Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.

干预措施: Emotional Disclosure and Brain Education (Behavioral)

Emotional Disclosure only

Active Comparator

Patients are interviewed about stress and other emotional issues only.

干预措施: Emotional Disclosure Only (Behavioral)

Pain Information Control

Placebo Comparator

Patients are interviewed about their pain history and experience.

干预措施: Pain Information Control (Behavioral)

结局指标

主要结局

Pain Intensity

时间窗: Change from Baseline to 1-month follow-up

Brief Pain Inventory (average of the 4 pain intensity rating items: highest, lowest, average, now). Range: 0.0 to 10.0 (higher = more severe pain)

次要结局

  • Emotional Distress(Change from Baseline to 1-month follow-up)
  • Pain Stages of Change Questionnaire(Change from Baseline to 1-month follow-up)
  • Pain Interference(Change from Baseline to 1-month follow-up)
  • Pain Catastrophizing Scale(Change from Baseline to 1-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark A. Lumley

Professor

Wayne State University

研究点 (1)

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