Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.

NCT ID: NCT04899297

Last Updated: 2024-05-08

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

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-07

Study Completion Date

2024-12-31

Brief Summary

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This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.

Detailed Description

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Conditions

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Quality of Life Spinal Deformity Scoliosis; Adolescence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Quality of life

Questionnaire

Intervention Type OTHER

All parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit.

Interventions

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Questionnaire

All parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis
* prescription of a brace or specific exercises for the child's vertebral deformity.

Exclusion Criteria

* Child with a history of spinal surgery
* Child with a history of significant diseases with possible impact on the quality of life of the parents
* Child with a history of spinal trauma
* Child with positive neurological evaluation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Scientifico Italiano Colonna Vertebrale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Zaina, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico Italiano Colonna Vertebrale

Locations

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ISICO

Milan, Mi, Italy

Site Status

Countries

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Italy

Other Identifiers

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PQOL-Isico

Identifier Type: -

Identifier Source: org_study_id

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