Clinical trial NCT04172142: Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls
Official title: Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pectus Deformity
Physical Disability
Psychosocial Impairment
Keywords: Pectus Carinatum
Pectus Excavatum
Physical Impairment
Psychosocial Impairment
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pectus Excavatum,Pectus Carinatum and Healthy Controls (10-18 years age)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: New York Posture Rating Chart
timeFrame: Baseline time
measure: International Physical Activity Questionnaire-Short Form (IPAQ) in the assessment of physical activity.
timeFrame: Baseline time
measure: Extended version of the Musculoskeletal Questionnaire (NMQ-E)
timeFrame: Baseline time
measure: Flexibility test
timeFrame: Baseline time
measure: Grip strength
timeFrame: Baseline time
measure: Abdominal muscle endurance
timeFrame: Baseline time
measure: Back strength
timeFrame: Baseline time
measure: Social Appearance Anxiety Scale
timeFrame: Baseline time
measure: Pediatric Quality of Life Inventory (PedsQL),
timeFrame: Baseline time
Secondary outcomes:
measure: Brief Symptom Inventory
timeFrame: Baseline time
measure: Body Image Scale (BIS)
timeFrame: Baseline time
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
Study officials:
References:
citation: Akkas Y, Gulay Peri N, Kocer B, Gulbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180.
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citation: Roberts J, Hayashi A, Anderson JO, Martin JM, Maxwell LL. Quality of life of patients who have undergone the Nuss procedure for pectus excavatum: Preliminary findings. J Pediatr Surg. 2003 May;38(5):779-83. doi: 10.1016/jpsu.2003.50166.
citation: Steinmann C, Krille S, Mueller A, Weber P, Reingruber B, Martin A. Pectus excavatum and pectus carinatum patients suffer from lower quality of life and impaired body image: a control group comparison of psychological characteristics prior to surgical correction. Eur J Cardiothorac Surg. 2011 Nov;40(5):1138-45. doi: 10.1016/j.ejcts.2011.02.019. Epub 2011 Mar 25.
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