跳至主要内容
临床试验/NCT06460909
NCT06460909招募中不适用

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Impact of preoperative psychological support on pain catastrophizing

研究概览

简要总结

Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery.

It is already well known that anxiety and catastrophizing predict postoperative pain.

The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery.

According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution.

Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus.

The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery.

The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).

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
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

  • •Adult over 18
  • •Independent, living in its own home
  • •Affiliated at a social security
  • •Consent signed
  • •Waiting for a Hallux Valgus surgery.

排除标准

  • •Not Able to understand french language
  • •Patient refusal
  • •Under guardianship
  • •Under french AME system

研究组 & 干预措施

Psychological support arm

Experimental

Patients randomized with psychological intervention.

干预措施: Psychological support (Other)

Without support

No Intervention

Patients with routine care with psychological support.

结局指标

主要结局

Impact of preoperative psychological support on pain catastrophizing

时间窗: at baseline

By State portion of the Spielberger State-Trait Anxiety Inventory STAI.

次要结局

  • Pain evaluate of catastrophizing patients(at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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