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NCT04899297 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
Quality of Life in Parents of Conservatively Treated Adolescents With Spinal Deformities: Development of a New Questionnaire.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04899297
Other study ID # PQOL-Isico
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 7, 2021
Est. completion date December 2023

Study information
Verified date February 2023
Source Istituto Scientifico Italiano Colonna Vertebrale
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Italy ISICO Milan Mi

Sponsors (1)
Lead Sponsor Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parents' quality of life New questionnaire developped to assess quality of life of parents of patients with spinal deformity treated conservatively through study completion, an average of 1 year
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