Scoliosis and Quality of Life of Adolescents

Scoliosis Clinical Trial

— SQUAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890654
• Other study ID #: RC31-15-7475
• Status: Completed
• Start date: September 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Other:
• First time measure
Initial Interview Initial Survey, Quality of life Scale Kinesitherapy Review Anxiety Scale
• Second time measure
Kinesitherapy review Second survey including numeric scale of pain Anxiety scale Scoliosis Research Society 22 quality of life scale
• Third time measure
Scoliosis Research Society 22 quality of life Scale Anxiety scale Numeric scale of pain Kinesitherapy review

Locations

Country	Name	City	State
France	Children Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary		1 Month before surgery
Primary	Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary		3 Month after surgery
Primary	Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary		6 months after the surgery
Secondary	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
Secondary	Comparison of pain before and after the surgery as assessed by visual scale of pain		1 Month before surgery
Secondary	Comparison of pain before and after the surgery as assessed by visual scale of pain		3 Months after surgery
Secondary	Comparison of anxiety before and after the surgery as assessed by anxiety scale		6 months after the surgery
Secondary	Patient global satisfaction before and after the surgery as assessed by oriented interviews		1 Month before surgery
Secondary	Patient global satisfaction before and after the surgery as assessed by oriented interviews		6 months after surgery
Secondary	Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back		1 Month before surgery
Secondary	Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back		3 months after the surgery
Secondary	Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back		6 months after the surgery