Scoliosis and Quality of Life of Adolescents

Completed

• Conditions: Scoliosis

• Registration Number: NCT02890654
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Primary Completion: 2018-09
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary	6 months after the surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children Hospital of Toulouse; 🇫🇷 Toulouse, France