Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls

November 22, 2019 updated by: Acibadem University
Chest wall deformities are the development of ribs, cartilage and sternum that form the chest wall together with isolated or abnormalities of the musculoskeletal system. Pectus excavatum and carinatum deformities are most common. It is reported that individuals with this problem have posture and physical impairments, difficulty in psychosocial relations and decreased quality of life.Therefore, in this study, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Pectus excavatum (PE) and pectus carinatum (PC) are the most common anterior chest-wall deformities. Both of these malformations predominantly affect males. They often coincide with the vulnerable life phase of puberty, a period characterized by great physical, social, and emotional changes. Outer appearance becomes a major issue for adolescents, and those who display a visible disfigurement may be put at a disadvantage, having to come to terms with a difference in their looks and having to face the risk of harassment by their peers. Patients with pectus deformities often experience feelings of shame and try to hide their chests. This can be reflected in the choice of clothing or poor body posture. Many patients even avoid social activities and sports. They are aware of the fact that their deformity is generally not considered attractive, and some regard it as an obstacle in future relationships. Reduced self-confidence and selfesteem appear to be rather common characteristics of PE patients. Recently, several authors have assessed the improvement of quality of life and body image following surgical repair of PE. Yet, little is known about the degree to which patients, differ from healthy individuals within the same age group. Steinmann et al observed reduced disease-specific and general health related quality in patients with a chest malformation. Body image was highly impaired in both PE and PC patients. However, the number of patients (71 PE, 19, PC, 82 healthy individuals) was not matched and was not evaluated physical function. Also, they evaluated patients with a high degree of preoperative deformity in this study. Therefore, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Recruiting
        • Acibadem University
        • Sub-Investigator:
          • Mustafa Yüksel, prof
        • Sub-Investigator:
          • İhsan Alaca, pt
        • Contact:
        • Principal Investigator:
          • Nuray Alaca, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pectus Excavatum,Pectus Carinatum and Healthy Controls (10-18 years age)

Description

Inclusion Criteria:

  • Diagnosis of chest wall deformity by doctor
  • Not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals

Exclusion Criteria:

  • Having chronic systemic disease
  • Genetic disease
  • Being psychologically diagnosed
  • Having additional musculoskeletal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Control group
Healthy individuals of similar age and sex who meet the inclusion criteria
Pectus Excavatum
Individuals with pectus excavatum that meet the inclusion criteria
Pectus Carinatum
Individuals with pectus excavatum that meet the inclusion criteria

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
New York Posture Rating Chart
Time Frame: Baseline time
The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments. 13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior). A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. higher the points better the postural alignment
Baseline time
International Physical Activity Questionnaire-Short Form (IPAQ) in the assessment of physical activity.
Time Frame: Baseline time
The questionnaire interrogates the last 7 days regarding the following activities: (1) Time (minutes) spent for vigorous physical activities (football, basketball, aerobics, or fast bicycling, heavy lifting, carrying loads, etc.), (2) Time (minutes) spent for moderate physical activities (carrying light load, bicycling at a regular pace, folk dances, bowling, tennis etc.), and (3) Time spent for walking and time spent for sitting in a day. Physical activity levels of the participants were classified into low [600 the metabolic equivalent of task (MET)-minute/week), moderate (600 to 3000 MET minute/week), and high (> 3000 MET- minute/week) activity groups based on total physical activity scores. higher the points better the physical activity.
Baseline time
Extended version of the Musculoskeletal Questionnaire (NMQ-E)
Time Frame: Baseline time
The extended version of the musculoskeletal questionnaire is completed by self-administration or face to face interview and provides reliable information on the onset, prevalence and outcomes of musculoskeletal pain in nine body regions (the neck, shoulder, upper back, elbow, wrist/hand, low back, hip/ thigh, knee, ankle/foot). The NMQ-E interrogates ache, pain or discomfort experienced in the nine body parts to date, for the last 12 months, for the last four weeks and on the day of the administration,with binary choice questions (yes or no).The frequency of the answer yes is high and shows us that musculoskeletal pain is high and is a bad score.
Baseline time
Flexibility test
Time Frame: Baseline time
bilateral sit-and-reach test: Sitting on the floor or a mat, legs straight and feet 8-12 inches apart, the person being tested reaches forward with the arms (hands overlapping). The distance of reach is measured in inches using a measuring line marked on the floor
Baseline time
Grip strength
Time Frame: Baseline time
The test is conducted with the participant seated on a chair (with a back and no arm rests), with the lower limbs resting on the ground. The shoulder of the limb to be tested remained adducted and neutral for rotation, with the elbow flexed at 90 °, the forearm neutral and wrist extension between 0 and 30 ° with 0-15 degrees of ulnar deviation. During the test, constant verbal encouragement was given to the participants to use their maximum strength. The test is repeated three times to obtain the mean.
Baseline time
Abdominal muscle endurance
Time Frame: Baseline time
Abdominal muscle endurance is measured as the number of correctly completed sit-ups in 30seconds. Sit-ups were performed with the hands placed at the side of the head, knees bent at 90°, and the feet secured by the investigator. A full sit-up is defined as touching the knees with the elbows and returning the shoulders to the ground. A higher number of completed sit-ups indicates greater abdominal muscle endurance.
Baseline time
Back strength
Time Frame: Baseline time
Back strength of the participants is measured using a Back-leg-chest dynamometer. The participant was positioned with body erect and knees bent so that the grasping hand rests at proper height. Then, by straightening the knees and lifting the chain of the dynamometer, pulling force is applied on the handle. The body would be inclined forward at an angle of 60 degrees for the measurement of back strength
Baseline time
Social Appearance Anxiety Scale
Time Frame: Baseline time
The scale a 16-item measure, was developed to assess the respondent's anxiety surrounding situations in which one's appearance may be evaluated. Response options for each item range from 1 (not at all) to 5 (extremely). The total score is calculated by summing across all items, after reverse coding the first item. Scores range from 16 to 80, with higher scores indicating greater fear
Baseline time
Pediatric Quality of Life Inventory (PedsQL),
Time Frame: Baseline time
QoL was measured with one of the three age-appropriate versions (5-7, 8-12, 13-18 years). This scale measures children's perceptions and reflects their concerns on the dimensions of physical health (8 items) and psychosocial health, the latter comprising the subdimensions of emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). The overall QoL score is obtained by adding up the scores for all dimensions. Children were asked to indicate on a 3-point (5-7 year version) or 5-point (8 years and older versions) Likert scale to what extent they had experienced difficulties regarding these dimensions over the last month (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). The answers were reverse-scored and rescaled to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A score of 100 represents the best possible QoL, a score of 0 the worst.
Baseline time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory
Time Frame: Baseline time
This instrument measures the participant's subjective experience of symptoms during the last week and includes 53 items rated on five-point Likert scales ranging from 0 (not at all) to 4 (very much). Nine symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism) are assessed and reflected as subscales. The total score of the instrument represents the Global Severity Index used in this study as an indicator of patients' overall symptoms. Total brief symptom inventory score, and scores on subscales, are computed as the sum of item-scores divided by the number of items. Higher scores indicate more severe psychiatric symptoms.
Baseline time
Body Image Scale (BIS)
Time Frame: Baseline time
Items of scale is associated a function ora part of the body. Each item has five possible choices as" I disagree strongly" , "I disagree" , "I am not sure", "I agree" and "I agree strongly". BIS item scores are from 1 to 5, total score varies between 40 and 200.A score of 135 and below from BIS is calculated as the body image is low
Baseline time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-17/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study protocol, individual participant data will be shared with the authors every two months

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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