NCT04782362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

March 2, 2021

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Pectus Excavatum Evaluation Questionnaire

    15-21 days

Interventions

Body image and quality of life of individuals who have used brace will be evaluated

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Pectus Carinatum

You may qualify if:

  • Patients who have been diagnosed with Pectus Carinatum by a doctor (2 cm above the protrusion level)
  • Between the ages of 10-18,
  • Having dissatisfaction with this defect

You may not qualify if:

  • Having severe scoliosis (Cobb angle over 20 degrees)
  • Having chronic systemic disease
  • Having a serious psychiatric illness
  • Having complex mixed type pectus deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pectus Carinatum

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCartilage DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

March 3, 2021

Primary Completion

September 18, 2021

Study Completion

October 20, 2021

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations