Scoliosis and Quality of Life of Adolescents (SQUAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis
• Intervention / Treatment: Other: First time measure; Other: Second time measure; Other: Third time measure

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Children Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Teenagers with diagnosis of idiopathic scoliosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Patient global satisfaction before and after the surgery as assessed by oriented interviews	6 months after surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back	1 Month before surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back	3 months after the surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back	6 months after the surgery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Agnès SUC, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Surgery; Teenagers; Multidisciplinary approach
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: RC31-15-7475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED