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NCT04782362 Clinical Trial

Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum

Quality of Life Clinical Trial

Official title:
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04782362
Other study ID # 2020-19/11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2021
Est. completion date October 20, 2021

Study information
Verified date October 2021
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In children with severe pectus carinatum, a significant loss of self-esteem, impairment in social behavior due to a decrease in quality of life associated with physical appearance and mental health has been reported. However, a questionnaire measuring these problems specific to this disease is not available in Turkish. Therefore, in our study, we aimed to investigate the validity and reliability of the Pectus Carinatum Body Image Quality of Life Questionnaire (PeCBI-QOL) in patients with Pectus Carinatum.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 20, 2021
Est. primary completion date September 18, 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 (2 cm above the protrusion level) 2. Between the ages of 10-18, 3. 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Brace Treatment
Body image and quality of life of individuals who have used brace 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 Body Image Quality of Life Questionnaire A questionnaire (Pectus Carinatum Body Image Quality of Life Questionnaire, PeCBI-QOL) was developed by Paulson et al. to be applied in the follow-up of Pectus Carinatum patients. The questionnaire includes 18 items for patients and 15 items for their families. The questionnaire has no validity and reliability in Turkish. 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
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