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

Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783948
• Other study ID #: 2020-19/09
• Status: Completed
• Start date: March 3, 2021
• Est. completion date: October 18, 2021

Study information

• Verified date: October 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 18, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brace
• Compliance
• Pectus Carinatum

Intervention

Other:
• Brace Treatment
Compliance to brace compression used for the correction of pectus carinatum will be evaluated.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15-21 days
Secondary	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.	15-21 days

External Links

•   Pectus Carinatum