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CompletedNCT04783948Updated Oct 22, 2021

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

An observational study in Pectus Carinatum, Compliance and Brace, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Acibadem University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
10 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pectus Carinatum
  • Compliance
  • Brace
03

In context

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Pectus Carinatum

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • OtherBrace Treatment

    Compliance to brace compression used for the correction of pectus carinatum will be evaluated.

06

What researchers measure

Primary outcomes

  1. Pectus Carinatum Evaluation Questionnaire

    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.

    Time frame: 15-21 days

Secondary outcomes

  1. The Pectus Excavatum Evaluation Questionnaire

    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.

    Time frame: 15-21 days

07

Study locations

1 site
  • Acibadem University
    Istanbul, 34752, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04783948
Lead sponsor
Acibadem University
Responsible party
Nuray Alaca (Assistant Professor, Acibadem University) — Principal investigator
First posted
Mar 5, 2021
Start date
Mar 3, 2021
Primary completion
May 3, 2021
Completion
Oct 18, 2021
Last update
Oct 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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