Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Scoliosis and Quality of Life of Adolescents (SQUAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890654
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Scoliosis Other: First time measure Other: Second time measure Other: Third time measure

Layout table for study information
Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
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
  • Initial Interview
  • Initial Survey,
  • Quality of life Scale
  • Kinesitherapy Review
  • Anxiety Scale

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Teenagers with diagnosis of idiopathic scoliosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890654


Locations
Layout table for location information
France
Children Hospital of Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Agnès SUC, MD University Hospital of Toulouse

Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02890654    
Other Study ID Numbers: RC31-15-7475
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Toulouse:
Teenagers
Multidisciplinary approach
Pain
Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases