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Completed

NCT Number: NCT04362878

Psychological Assessment of Patients With Chest Wall Deformities

The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Pectus Carinatum Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meyer Children's Hospital

Florence, 50139, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of pectus excavatum or pectus carinatum;
  • Age from 12 to 18 years old;
  • High level of fluency in Italian.

Exclusion criteria

  • Clinical diagnosis of chronic or acute disease, or presence of other conditions which could significantly influence adolescents' quality of life, mental health, body image and self-esteem;
  • Diagnosis of intellectual disability or other conditions (e.g. low level of fluency in Italian) which could hinder questionnaires understanding.

Treatment and study plan

Primary outcomes

  1. Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.

    Time frame: Baseline.

    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.

  2. Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.

    Time frame: Baseline

    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.

  3. Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.

    Time frame: Baseline

    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.

  4. Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).

    Time frame: Baseline.

    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.

Secondary outcomes

  1. Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients with different severity indexes.

    Time frame: Baseline.

    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.

  2. Differences in body image mean scores on the Body Uneasiness Test (BUT) between PE and PC patients.

    Time frame: Baseline.

    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.

  3. Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.

    Time frame: Baseline.

    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.

  4. Correlation among body image scores on the Body Uneasiness Test (BUT) and mental health scores on the Youth Self-Report (YSR).

    Time frame: Baseline.

    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.

  5. Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.

    Time frame: Baseline.

    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.

  6. Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.

    Time frame: Baseline.

    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.

  7. Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.

    Time frame: Baseline.

    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.

  8. Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).

    Time frame: Baseline.

    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.

  9. Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.

    Time frame: Baseline.

    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.

  10. Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.

    Time frame: Baseline.

    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.

  11. Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients in different age ranges.

    Time frame: Baseline.

    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.

  12. 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).

    Time frame: Baseline.

    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.

  13. Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).

    Time frame: One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.

    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.

Other outcomes

  1. Degree of the severity of malformation rated on a six-point classification.

    Time frame: Baseline.

    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.

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Meyer Children's Hospital IRCCS

Registry information

Official study title

Evaluation of Mental Health, Self-esteem, Body Image and Quality of Life in Patients With Pectus Excavatum or Pectus Carinatum: Relationship With Severity and Type of the Deformity, and Patients' Age

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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