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

• Sponsor: Acibadem University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04782362
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pectus Carinatum; Quality of Life; Body Image; Brace	Other: Brace Treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
• Actual Study Start Date: Mar 3, 2021
• Actual Primary Completion Date: Sep 18, 2021
• Actual Study Completion Date: Oct 20, 2021

Outcome Measures

Primary Outcome Measures

1. Pectus Carinatum Body Image Quality of Life Questionnaire [15-21 days]

   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.

Secondary Outcome Measures

1. The Pectus Excavatum Evaluation Questionnaire [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem University	Istanbul		Turkey	34752

Sponsors and Collaborators

• Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pectus Carinatum

Publications

None provided.

• Responsible Party: Nuray Alaca, Assistant Professor, Acibadem University
• ClinicalTrials.gov Identifier: NCT04782362
• Other Study ID Numbers: 2020-19/11
• First Posted: Mar 4, 2021
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pectus Carinatum

Study Results

No Results Posted as of Oct 22, 2021