NCT07671430招募中不适用
Assessment of the Benefits of Psychological Care Before Anterior Cruciate Ligament Surgery of the Knee (CLIPPER)
GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年5月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Compare the intensity of postoperative pain between the two groups during the night following the procedure
研究概览
简要总结
The primary objective of this study is to assess the impact of a preoperative psychological consultation on postoperative pain in anxious patients undergoing primary anterior cruciate ligament reconstruction surgery.
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
- None
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
- •Patient having signed the consent form for participation in the study
- •Patient scheduled for first-line outpatient ACL reconstruction surgery
- •Patient with a score >30 on the SFQ questionnaire (which assesses fear of surgery)
- •Patient with the ability to connect to the internet and follow a teleconsultation on a screen
排除标准
- •Surgical history of the operated knee
- •History of psychiatric disorders and/or regular use of psychotropic medication
- •Regular use of opioid medication
- •Mental disability or any other reason that may hinder understanding or strict adherence to the protocol
- •Patient not affiliated with the French social security system
- •Patient under legal protection, guardianship or curatorship
- •Pregnant, breastfeeding or childbearing women without effective contraception
- •A patient who is already enrolled in another therapeutic study protocol or who has participated in another trial within the past three months
结局指标
主要结局
Compare the intensity of postoperative pain between the two groups during the night following the procedure
时间窗: First night following surgery
The maximum pain intensity experienced during the first night after surgery is measured using a numerical rating scale (NRS)
次要结局
未报告次要终点
研究者
研究点 (1)
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