Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum

October 21, 2021 updated by: Nuray Alaca, Acibadem University
Based on the hypothesis that the chest wall was still pliable in adolescence and could be reshaped in a normal position with the external suppressor applied on the chest, a pressure orthosis was started to be used in the pectus carinatum. It is the focus of attention as it is an alternative method to surgery for patients. However, the patient's compliance with the orthosis is difficult. Therefore, in our study, we aimed to investigate the Turkish Validity and Reliability of the Pectus Carinatum Evaluation Questionnaire, which is a questionnaire investigating the compliance with orthosis treatment in patients diagnosed with Pectus Carinatum by the doctor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

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

  • Turkey
      • Istanbul, Turkey, 34752
        • Acibadem University

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

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Pectus Carinatum

Description

Inclusion Criteria:

  1. Patients who have been diagnosed with Pectus Carinatum by a doctor, have an orthosis indication (2 cm above the protrusion level) and who are given the orthosis for the first time
  2. Having a correction pressure below 10 pounds per square inch (PSI) in the compression test
  3. Between the ages of 10-18,
  4. Having dissatisfaction with this defect

Exclusion Criteria:

  1. Having severe scoliosis (Cobb angle over 20 degrees)
  2. Having chronic systemic disease
  3. Having a serious psychiatric illness
  4. Having complex mixed type pectus deformity

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pectus Carinatum Evaluation Questionnaire
Time Frame: 15-21 days
A questionnaire (Pectus Carinatum Evaluation Questionnaire, PCEQ) was developed by Pessanha et al to be applied in the follow-up of Pectus Carinatum patients. The PCEQ was divided into four different sections, allowing a thorough evaluation of compliance, symptoms, social influence and engagement with sports and daily activities.
15-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pectus Excavatum Evaluation Questionnaire
Time Frame: 15-21 days
The Pectus Excavatum Evaluation Questionnaire (PEEQ) was developed and validated by Lawson et al to measure the physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum. Each of the 17 items in the PEEQ is in a Likert scale format, where low scores indicate better outcome.
15-21 days

Collaborators and Investigators

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

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

March 3, 2021

Primary Completion (ACTUAL)

May 3, 2021

Study Completion (ACTUAL)

October 18, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (ACTUAL)

March 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-19/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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