Skip to main content
OpenTrials
Completed

NCT Number: NCT02890654

Scoliosis and Quality of Life of Adolescents

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First time measure

Other
  • Initial Interview
  • Initial Survey,
  • Quality of life Scale
  • Kinesitherapy Review
  • Anxiety Scale

Second time measure

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

Third time measure

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

Primary outcomes

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

    Time frame: 1 Month before surgery

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

    Time frame: 3 Month after surgery

  3. 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

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

    Time frame: 1 Month before surgery, 3 months and 6 months after the surgery

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

    Time frame: 1 Month before surgery

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

    Time frame: 3 Months after surgery

  4. Comparison of anxiety before and after the surgery as assessed by anxiety scale

    Time frame: 6 months after the surgery

  5. Patient global satisfaction before and after the surgery as assessed by oriented interviews

    Time frame: 1 Month before surgery

  6. Patient global satisfaction before and after the surgery as assessed by oriented interviews

    Time frame: 6 months after surgery

  7. Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back

    Time frame: 1 Month before surgery

  8. Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back

    Time frame: 3 months after the surgery

  9. Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back

    Time frame: 6 months after the surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: SQUAD

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 7, 2016
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.