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临床试验/NCT02890654
NCT02890654已完成不适用

Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary

研究概览

简要总结

Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow.

To date in France, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made.

The present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. Focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery.

Help teens reclaim their bodies after the changes caused by the intervention is a major issue.

This study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term.

Medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...).

The present study would systematize data collections in order to have a comprehensive and accurate assessment of the care.

The qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients followed for idiopathic scoliosis with indication for surgery
  • Patients monitored and operated at the Children Hospital of Toulouse

排除标准

  • Opposition to the participation
  • Spine deformations other than scoliosis
  • Non idiopathic scoliosis

结局指标

主要结局

Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary

时间窗: 6 months after the surgery

次要结局

  • Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back(6 months after the surgery)
  • Comparison of pain before and after the surgery as assessed by visual scale of pain(3 Months after surgery)
  • Comparison of anxiety before and after the surgery as assessed by anxiety scale(6 months after the surgery)
  • Patient global satisfaction before and after the surgery as assessed by oriented interviews(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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