跳至主要内容
临床试验/NCT03773198
NCT03773198已完成3 期

Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年4月5日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
86
试验地点
2
主要终点
anxiety-state

研究概览

简要总结

The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Patient who has given oral consent
  • Adult patient requiring scheduled conventional orthopedic surgery of the upper limb (wrist, elbow, shoulder) or lower limb (ankle, foot, knee, hip)

排除标准

  • Patient not affiliated to a national health insurance system,
  • Patient subject to a legal protection measure (curatorship, guardianship)
  • Patient subject to a justice protection measure
  • Pregnant, parturient or breastfeeding woman
  • Patient unable to give consent
  • Patient with a pace maker
  • Patient with cognitive problems: Alzheimer's, senile dementia
  • Patient who has already received ERCS as part of surgery
  • Patient who does not speak or understand French
  • Patient with psychiatric disorders: major depression, bipolar disorder, addictive disorders, psychotic disorders (psychosis, schizophrenia, acute delirium)

结局指标

主要结局

anxiety-state

时间窗: During the surgical procedure

Evolution of the patient's anxiety, between the entry and exit of the surgical department measured by the Spielberger state anxiety inventory, which is intended to evaluate an emotional reaction at a given time represented here by the operating room.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验