Scoliosis and Quality of Life of Adolescents

NCT ID: NCT02890654

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

First time measure

Intervention Type OTHER

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

Second time measure

Intervention Type OTHER

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

Third time measure

Intervention Type OTHER

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

Interventions

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First time measure

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

Intervention Type OTHER

Second time measure

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

Intervention Type OTHER

Third time measure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnès SUC, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

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Children Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31-15-7475

Identifier Type: -

Identifier Source: org_study_id

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