Psychological Assessment of Patients With Chest Wall Deformities

March 15, 2023 updated by: Daniela Graziani, University of Florence

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

209

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 Backup

Study Locations

  • Italy
      • Florence, Italy, 50139
        • Meyer Children's Hospital

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

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline.
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.
Baseline
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.
Baseline
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.
Baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
Baseline.
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.
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).
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.
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).
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.
One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline.

Collaborators and Investigators

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

Sponsor

University of Florence

Collaborators

Meyer Children's Hospital IRCCS

Investigators

  • Study Director: Martin Rosanna, PsyD, Meyer Children's Hospital IRCCS

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)

October 8, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 176/2019

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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