Clinical trial NCT02890654: Scoliosis and Quality of Life of Adolescents
Official title: Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Teenagers
Multidisciplinary approach
Pain
Surgery
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 95
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teenagers with diagnosis of idiopathic scoliosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
timeFrame: 1 Month before surgery
measure: Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
timeFrame: 3 Month after surgery
measure: Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: Comparison of pain before and after the surgery as assessed by visual scale of pain
timeFrame: 1 Month before surgery, 3 months and 6 months after the surgery
measure: Comparison of pain before and after the surgery as assessed by visual scale of pain
timeFrame: 1 Month before surgery
measure: Comparison of pain before and after the surgery as assessed by visual scale of pain
timeFrame: 3 Months after surgery
measure: Comparison of anxiety before and after the surgery as assessed by anxiety scale
timeFrame: 6 months after the surgery
measure: Patient global satisfaction before and after the surgery as assessed by oriented interviews
timeFrame: 1 Month before surgery
measure: Patient global satisfaction before and after the surgery as assessed by oriented interviews
timeFrame: 6 months after surgery
measure: Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
timeFrame: 1 Month before surgery
measure: Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
timeFrame: 3 months after the surgery
measure: Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Children Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Agnès SUC, MD
role: PRINCIPAL_INVESTIGATOR
References: