NCT05818969已完成不适用
Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)
研究概览
简要总结
The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Diagnosis of primary knee arthritis, in need of a total knee arthroplasty.
- •The ability to read, speak, and understand English
- •The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer
- •18 years of age or older
排除标准
- •Revision total knee arthroplasty
- •Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery
- •Patients with active cancer or receiving palliative care
结局指标
主要结局
Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Patient-reported anxiety in the perioperative period
次要结局
- Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)
- Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)
- Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)
研究者
研究点 (2)
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