Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain assessed by Visual Analog Scale
研究概览
简要总结
The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis
详细描述
Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •diagnosis of knee osteoarthritis
- •indication for a lavage
排除标准
- •People who have had both knees washed on the same day.
- •People who have already received a joint lavage.
- •Patients with psychotic disorders.
- •Refusal to participate.
- •People who do not understand and/or speak French or who are deaf.
研究组 & 干预措施
CONTROL
Standard care
Hypnosis
Standard care + intervention
干预措施: Hypnosis (Other)
结局指标
主要结局
Pain assessed by Visual Analog Scale
时间窗: One Day, at end of lavage procedure
VAS range 0-10, 10 for most severe pain
次要结局
- Operator Impact(Over 1 week after lavage procedure)
- Anxiety assessed by Visual Analog Scale(Day 1, at end of lavage procedure)
- Pain assessed by Visual Analog Scale(Day 7, after lavage procedure)
- Gesture tolerability(Day 1, at end of lavage procedure)
- Analgesics consumption(Over 1 week after lavage procedure)