Factors Affecting Guided Imagery Response in Total Knee Replacement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- function
研究概览
简要总结
The purpose of this mixed methods pilot study is to produce preliminary data for a randomized, placebo-controlled trial testing a biobehavioral model of the effects of guided imagery on outcomes of total knee replacement surgery.
详细描述
The study uses a mixed-method design (quantitative experimental pilot study with qualitative descriptive and multiple case study methods) to address the study aims:
AIM 1: Generate estimates of effect sizes and assess feasibility of procedures for a future RCT testing a model of a standardized, prerecorded guided imagery intervention on functional outcomes of TKR.
AIM 2: Elucidate the GI responder mechanism through analysis of the effect of imaging ability and other potential moderators on guided imagery's effects on TKR outcomes.
AIM 3: Analyze the effect of guided imagery on outcome expectancy, psychological distress, rehabilitation commitment and neuroimmune activation as mediators on TKR functional outcomes.
AIM 4: Identify patients' perspectives related to receiving, and participating in a study of, guided imagery intervention for total knee replacement surgery (TKR).
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
- 否
入选标准
- •scheduled for a single TKR
- •attendance at the hospital joint replacement class
- •ability to speak, read, and write English -
排除标准
- •current or planned use of guided imagery
- •history of previous total joint replacement
- •current enrollment in another clinical studY
- •current treatment in a pain management program
- •current diagnosis of immune disorders (e.g., rheumatoid arthritis, organ transplant, cancer, HIV, SLE)
- •use of immune altering medications in past month
- •comorbidities that would limit participation in study procedures or postoperative rehabilitation and/or impair recovery (e.g., psychosis; sensory, cognitive, neurologic or motor impairment
- •vision or hearing deficits
- •lymphedema
- •morbid obesity [BMI > 40])
- •reported diagnosis of anemia
研究组 & 干预措施
GUIDED IMAGERY
干预措施: GUIDED IMAGERY (Behavioral)
AUDIO BOOK
干预措施: PLACEBO (Behavioral)
结局指标
主要结局
function
时间窗: 6 months
WOMAC AND SF-36
次要结局
未报告次要终点
研究者
ANN F JACOBSON
Professor, College of Nursing
Kent State University