An observational study in Pectus Excavatum and Pectus Carinatum, sponsored by University of Florence. Completed at 1 site in Italy. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by University of Florence · Observational
The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.
The study aims at providing psychological assessment (body image, self-esteem, overall mental health) and quality of life investigation of adolescents affected by chest wall deformities, in relation to the severity and type of deformity, and patients' age; identifying risk factors for psychological disorders.
The following hypotheses were tested: differences between patients with different chest wall deformities regarding body image and mental health were expected; no hypothesis on the possible results concerning the effect of the severity of deformity on each studied variable was formulated, since previous findings are unclear. Concerning age, some differences according to different age ranges were expected. Regarding risk factors for mental health problems, older age and greater body image dissatisfaction were expected to be significant risk factors for psychological problems; regarding the severity and type of deformity, results of previous studies are unclear or lacking, so no hypothesis was tested; quality of life and self-esteem variables were also tested, as previous studies showed they are significantly related to general well being and mental health in adolescents.
Adolescents coming at the outpatient clinics for the first evaluation of their chest wall and one of their parents/caregivers were enrolled. After the medical examination, patients meeting inclusion criteria are invited to participate in the study and to be assessed by a trained psychologist who administered them all questionnaires after they expressed their informed consent.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 209 is above the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adolescents coming for the first medical examination of their chest wall at the Pectus Center outpatient clinic will be invited to participate in the study. Adolescents who express their voluntary participation will be enrolled. One of their parents/caregivers is also invited to take part in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Time frame: Baseline.
Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Time frame: Baseline
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.
The YSR 11-18 is a validated self-report measure of 11-18 years old adolescents' social competences, behavioral and emotional problems. Different cut-off scores are provided according to age and gender to identify scores in the normal, borderline or clinical range.
Time frame: Baseline
Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).
The CBCL 6-18 is a questionnaire to be filled out by parents to assess social competence and behavioral and emotional problems in children and adolescents aged 6 to 18 years old; different cut-off scores are provided according to children's/adolescents' age and gender to identify scores in the normal, borderline or clinical range.
Time frame: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients with different severity indexes.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Time frame: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) between PE and PC patients.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Time frame: Baseline.
Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Time frame: Baseline.
Correlation among body image scores on the Body Uneasiness Test (BUT) and mental health scores on the Youth Self-Report (YSR).
The BUT is a self-report measure of the overall body perception (BUT-A) and specific body parts or functions perception (BUT-B). It has been validated on a sample of participants from 13 to over 65 years old. Higher scores correspond to greater body uneasiness.
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Time frame: Baseline.
Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Time frame: Baseline.
Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).
The RSES is validated self-report measures of self-esteem, widely used in adolescents. Higher scores correspond to higher self-esteem. A score of lower than 15 indicates low self-esteem.
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Time frame: Baseline.
Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients in different age ranges.
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Time frame: Baseline.
Correlation among quality of life scores on the Pediatric Quality of life Inventory (Peds-Ql) and mental health scores on the Youth Self-Report (YSR).
The Peds-Ql is a validated self-report measure of the quality of life in children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents version and the 13-18 years old adolescents version are used. Higher scores indicated a better quality of life.
Time frame: Baseline.
Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).
The Peds-Ql (parent version) is a validated tool filled out by parents of children and adolescents in different age ranges. For the present study, the 8-12 years old early-adolescents' parent version and the 13-18 years old adolescents' parent version are used. Higher scores indicated a better quality of life.
Time frame: One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.
Degree of the severity of malformation rated on a six-point classification.
The severity of the deformity was rated according to six severity classes, from 0= absent to 5=extremely severe. This classification method was developed from a 3D scanner procedure and it demonstrated to outperform traditional classification methods.
Time frame: Baseline.
Ran from Oct 2019 to primary completion in Feb 2021, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florence