跳至主要内容
临床试验/NCT07658326
NCT07658326招募中不适用

Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy

GCS Ramsay Santé pour l'Enseignement et la Recherche3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月28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
100
试验地点
3
主要终点
Stress will be assessed using the MSP9 score.

研究概览

简要总结

Orthopedic surgery of the limbs presents a unpredictable postoperative course, which can be more or less lengthy in terms of functional recovery and resumption of personal or professional activities. Not uncommon, convalescence can require many months with dramatic personal and/or socio-professional consequences (disability, unemployment, etc.), particularly in the postoperative development of complex regional pain syndrome (CRPS) and/or adhesive capsulitis.

Among the suspected contributing factors, the existence of an unfavorable preoperative psychological context in patients is often mentioned.

This research is based on the hypothesis that a high level of preoperative stress in patients could contribute to the occurrence of more significant postoperative complications in patients who have undergone shoulder surgery.

The main objective is to measure the level of preoperative stress in patients undergoing surgery for rotator cuff tendinopathy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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, male or female, over 18 years of age
  • First-line surgery for rotator cuff tendinopathy (torn and untorn)
  • Subject affiliated with or covered by a social security scheme
  • Collection of the patient's non-opposition to participate in the study

排除标准

  • Patients with medical history of adhesive capsulitis or complex regional pain syndrome (CRPS)
  • Patients with a history of diabetes or thyroid dysfunction
  • Patients with a history of fibromyalgia
  • Patients with a history of mental illness (PMD, schizophrenia)
  • Patients taking antidepressants or similar medications
  • Patients participating in another clinical trial
  • Protected patients: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
  • Pregnant, breastfeeding, or parturient women;
  • Patients hospitalized without their consent.

研究组 & 干预措施

patient undergoing surgery for rotator cuff tendinopathy

干预措施: Questionnaires (Other)

结局指标

主要结局

Stress will be assessed using the MSP9 score.

时间窗: Preoperation

This score ranges from 9 to 72 based on a rating scale of 1 to 8 (reversed for positive items): * 9-26 - Very low stress level * 27-44 - Low stress level * 45-54 - Moderate stress level * 55-63 - High stress level * 64-72 - Very high stress level

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 (3)

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