Pectus DeformityNCT04172142
Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls
An observational study of Pectus Deformity and Physical Disability, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Deformity, Physical Disability, Psychosocial Impairment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2019to 15 Aug 2020
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: Pectus Excavatum,Pectus Carinatum and Healthy Controls (10-18 years age)
Who may be able to join
- Diagnosis of chest wall deformity by doctor
- Not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals
Who cannot join
- Having chronic systemic disease
- Genetic disease
- Being psychologically diagnosed
- Having additional musculoskeletal diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul
Nuray Alaca, PhD, +9005324251290, nuray.alaca@acibadem.edu.tr
Nuray Alaca, PhD
About this study
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.
Read the 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.
- Keywords
- Pectus Carinatum, Pectus Excavatum, Physical Impairment, Psychosocial Impairment
- Medical subject headings
- Pectus Carinatum, Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
New York Posture Rating Chart
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
Measured: Baseline time
International Physical Activity Questionnaire-Short Form (IPAQ) in the assessment of physical activity.
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.
Measured: Baseline time
Extended version of the Musculoskeletal Questionnaire (NMQ-E)
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.
Measured: Baseline time
Flexibility test
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
Measured: Baseline time
Grip strength
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.
Measured: Baseline time
Abdominal muscle endurance
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.
Measured: Baseline time
Back strength
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
Measured: Baseline time
Social Appearance Anxiety Scale
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
Measured: Baseline time
Pediatric Quality of Life Inventory (PedsQL),
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.
Measured: Baseline time
Secondary outcomes (2)
Brief Symptom Inventory
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.
Measured: Baseline time
Body Image Scale (BIS)
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
Measured: Baseline time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start7 Nov 2019
- Primary completion15 May 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pectus DeformityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172142
- Sponsor's protocol ID
- 2019-17/15
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, individual participant data will be shared with the authors every two months
Publications
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.
PubMed 30541247Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.
PubMed 25883894Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.
PubMed 16646710Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.
PubMed 18996250Blanco FC, Elliott ST, Sandler AD. Management of congenital chest wall deformities. Semin Plast Surg. 2011 Feb;25(1):107-16. doi: 10.1055/s-0031-1275177.
PubMed 22294949Hart TA, Flora DB, Palyo SA, Fresco DM, Holle C, Heimberg RG. Development and examination of the social appearance anxiety scale. Assessment. 2008 Mar;15(1):48-59. doi: 10.1177/1073191107306673.
PubMed 18258731Sahin NH, Durak Batigun A, Ugurtas S. [The validity, reliability and factor structure of the Brief Symptom Inventory (BSI)]. Turk Psikiyatri Derg. 2002 Summer;13(2):125-35. Turkish.
PubMed 12794665Einsiedel E, Clausner A. Funnel chest. Psychological and psychosomatic aspects in children, youngsters, and young adults. J Cardiovasc Surg (Torino). 1999 Oct;40(5):733-6.
PubMed 10597013Harkonen R, Piirtomaa M, Alaranta H. Grip strength and hand position of the dynamometer in 204 Finnish adults. J Hand Surg Br. 1993 Feb;18(1):129-32. doi: 10.1016/0266-7681(93)90212-x.
PubMed 8436850Lockie R, Schultz A, Callaghan S, Jordan C, Luczo T, Jeffriess M. A preliminary investigation into the relationship between functional movement screen scores and athletic physical performance in female team sport athletes. Biol Sport. 2015 Mar;32(1):41-51. doi: 10.5604/20831862.1127281. Epub 2014 Nov 3.
PubMed 25729149Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.
PubMed 19047237Roberts 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.
PubMed 12720193Steinmann 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.
PubMed 21440452Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499WELCH KJ. Satisfactory surgical correction of pectus excavatum deformity in childhood; a limited opportunity. J Thorac Surg. 1958 Nov;36(5):697-713. No abstract available.
PubMed 13588724
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls
- ClinicalTrials.gov ID
- NCT04172142
- Acronym / sponsor ID
- 2019-17/15
- Keywords
- Pectus Carinatum, Pectus Excavatum, Physical Impairment, Psychosocial Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 21 Nov 2019 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pectus Excavatum,Pectus Carinatum and Healthy Controls (10-18 years age)
Key inclusion criteria (2 listed)
- Diagnosis of chest wall deformity by doctor
- Not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals
Key exclusion criteria (4 listed)
- Having chronic systemic disease
- Genetic disease
- Being psychologically diagnosed
- Having additional musculoskeletal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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
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.
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.
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
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
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.
2 secondary outcomes
Brief Symptom Inventory
Time frame: Baseline time
Body Image Scale (BIS)
Time frame: Baseline time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 30541247Akkas 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.
- Background: PubMed 25883894Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.
- Background: PubMed 16646710Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.
- Background: PubMed 18996250Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.
- Background: PubMed 22294949Blanco FC, Elliott ST, Sandler AD. Management of congenital chest wall deformities. Semin Plast Surg. 2011 Feb;25(1):107-16. doi: 10.1055/s-0031-1275177.
- Background: PubMed 18258731Hart TA, Flora DB, Palyo SA, Fresco DM, Holle C, Heimberg RG. Development and examination of the social appearance anxiety scale. Assessment. 2008 Mar;15(1):48-59. doi: 10.1177/1073191107306673.
- Background: PubMed 12794665Sahin NH, Durak Batigun A, Ugurtas S. [The validity, reliability and factor structure of the Brief Symptom Inventory (BSI)]. Turk Psikiyatri Derg. 2002 Summer;13(2):125-35. Turkish.
- Background: PubMed 10597013Einsiedel E, Clausner A. Funnel chest. Psychological and psychosomatic aspects in children, youngsters, and young adults. J Cardiovasc Surg (Torino). 1999 Oct;40(5):733-6.
- Background: PubMed 8436850Harkonen R, Piirtomaa M, Alaranta H. Grip strength and hand position of the dynamometer in 204 Finnish adults. J Hand Surg Br. 1993 Feb;18(1):129-32. doi: 10.1016/0266-7681(93)90212-x.
- Background: PubMed 25729149Lockie R, Schultz A, Callaghan S, Jordan C, Luczo T, Jeffriess M. A preliminary investigation into the relationship between functional movement screen scores and athletic physical performance in female team sport athletes. Biol Sport. 2015 Mar;32(1):41-51. doi: 10.5604/20831862.1127281. Epub 2014 Nov 3.
- Background: PubMed 19047237Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.
- Background: PubMed 12720193Roberts 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.
- Individual participant dataSharing planned: Undecided. Study protocol, individual participant data will be shared with the authors every two months
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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.
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 Deformity and Physical Disability, 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 2 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuray Alaca, PhD (+905324251290, nuray.alaca@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New York Posture Rating Chart (time frame: Baseline time). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172142, which also lists 15 linked publications.
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 25 Nov 2019.