Psychosocial Support for Pre-operative Pain and Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 727
- 试验地点
- 2
- 主要终点
- Pain Unpleasantness Numeric Rating Scale
研究概览
简要总结
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Clinical assessors were masked at postoperative follow-up
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
- •English-speaking males or females
- •18 years old or older
- •patients within the University of Utah Hospital system
- •patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery
排除标准
- •Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
结局指标
主要结局
Pain Unpleasantness Numeric Rating Scale
时间窗: Immediately prior to and following intervention
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Pain Intensity Numeric Rating Scale
时间窗: Immediately prior to and following intervention
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
次要结局
- Sensation Manikin Body Sensation Report(Immediately prior to and following intervention)
- Pain Medication Desire Numeric Rating Scale(Immediately prior to and following intervention)
- Anxiety Numeric Rating Scale(Immediately prior to and following intervention)
- Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0(During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.)
- Nondual Awareness Dimensional Assessment - State(Immediately prior to and following intervention)
研究者
Eric Garland
Associate Dean for Research College of Social Work Director; Center on Mindfulness and Integrative Health Intervention Development (C-MIIND)
University of Utah