Scoliosis and Quality of Life of Adolescents

NCT02890654 | Completed

• 1 other identifier: RC31-15-7475
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Teenagers; Multidisciplinary approach; Pain; Surgery

Outcome Measures

Primary Outcomes (3)

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

  1 Month before surgery

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

  3 Month after surgery

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

  6 months after the surgery

Secondary Outcomes (9)

• Comparison of pain before and after the surgery as assessed by visual scale of pain

  1 Month before surgery, 3 months and 6 months after the surgery

• Comparison of pain before and after the surgery as assessed by visual scale of pain

  1 Month before 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

  1 Month before surgery

Study Arms (1)

Teenagers with scoliosis

Patients will be evaluated at three times during the study : * First time measure : 1 month before the scoliosis surgery * Second time measure : 3 months after the scoliosis surgery * Third time measure : 1 year after the scoliosis surgery

Other: First time measure; Other: Second time measure; Other: Third time measure

Interventions

First time measure OTHER

* Initial Interview * Initial Survey, * Quality of life Scale * Kinesitherapy Review * Anxiety Scale

Teenagers with scoliosis

Second time measure OTHER

* Kinesitherapy review * Second survey including numeric scale of pain * Anxiety scale * Scoliosis Research Society 22 quality of life scale

Teenagers with scoliosis

Third time measure OTHER

* Scoliosis Research Society 22 quality of life Scale * Anxiety scale * Numeric scale of pain * Kinesitherapy review

Teenagers with scoliosis

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Teenagers with diagnosis of idiopathic scoliosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Children Hospital of Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Scoliosis; Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agnès SUC, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

FR (1)