Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 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
研究组 & 干预措施
Hypnosis Therapy Group
Experimental: Hypnosis Therapy Group
Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication & study doctor will be the same as any total knee arthroplasty regardless of study participation.
干预措施: Hypnosis Therapy (Behavioral)
Control Care Group
No Intervention: Control Care Group
Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided information to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication & study doctor will be the same as any total knee arthroplasty regardless of study participation.
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)