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

February 28, 2023 updated by: Istituto Scientifico Italiano Colonna Vertebrale

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Mi
      • Milan, Mi, Italy, 20141
        • Recruiting
        • ISICO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents of adolescents with spinal deformities treated in a tertiary referral outpatient center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Quality of life
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' quality of life
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Investigators

  • Principal Investigator: Fabio Zaina, MD, Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PQOL-Isico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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