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Clinical Trials/NCT02890654
NCT02890654
Completed
Not Applicable

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

University Hospital, Toulouse1 site in 1 country95 target enrollmentStarted: September 2015Last updated:
ConditionsScoliosis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
95
Locations
1
Primary Endpoint
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months after the surgery

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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