Pectus CarinatumNCT04782362
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
An observational study of Pectus Carinatum and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pectus Carinatum, Quality of Life, Body Image
- What is being tested?
- Brace Treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2021to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Pectus Carinatum
Who may be able to join
- 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
Who cannot join
- Having severe scoliosis (Cobb angle over 20 degrees)
- Having chronic systemic disease
- Having a serious psychiatric illness
- Having complex mixed type pectus deformity
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pectus Carinatum, Quality of Life, Body Image, Brace
- Being tested
- Brace Treatment
- Medical subject headings
- Pectus Carinatum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brace TreatmentOther
Body image and quality of life of individuals who have used brace will be evaluated
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start3 Mar 2021
- Primary completion18 Sep 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus CarinatumStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782362
- Sponsor's protocol ID
- 2020-19/11
- Status last verified
- Oct 2021
- First submitted
- 2 Mar 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
- ClinicalTrials.gov ID
- NCT04782362
- Acronym / sponsor ID
- 2020-19/11
- Conditions
- Pectus Carinatum, Quality of Life, Body Image, Brace
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Pectus Carinatum
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Having severe scoliosis (Cobb angle over 20 degrees)
- Having chronic systemic disease
- Having a serious psychiatric illness
- Having complex mixed type pectus deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brace TreatmentBody image and quality of life of individuals who have used brace will be evaluated | Other | – |
Primary outcome
Pectus Carinatum Body Image Quality of Life Questionnaire
Time frame: 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.
1 secondary outcome
The Pectus Excavatum Evaluation Questionnaire
Time frame: 15-21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Pectus CarinatumLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pectus Carinatum
RecruitingObservational study
Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
Pectus Carinatum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Carinatum and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pectus Carinatum Body Image Quality of Life Questionnaire (time frame: 15-21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.