Psychological Assessment of Patients With Chest Wall Deformities

NCT04362878 | Completed

• 1 other identifier: 176/2019
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pectus Excavatum; Pectus Carinatum

Keywords

Pectus excavatum; Pectus carinatum; Adolescents; Psychological Assessment; Quality of life

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline.

Secondary Outcomes (13)

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

  Baseline.

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

  Baseline.

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

  Baseline.

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

  Baseline.

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

  Baseline.

Other Outcomes (1)

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

  Baseline.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florence: lead
• Meyer Children's Hospital IRCCS: collaborator

Study Sites (1)

Meyer Children's Hospital

Florence, 50139, Italy

Location

Related Publications (7)

• Li H, Jin X, Fan S, Wang D, Wu C, Pan Z, Li Y, An Y, Wang G, Dai J, Wang Q. Behavioural disorders in children with pectus excavatum in China: a retrospective cohort study with propensity score matching and risk prediction model. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):596-603. doi: 10.1093/ejcts/ezz038.

  PMID: 30824916 BACKGROUND

• 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.

  PMID: 21440452 BACKGROUND

• Luo L, Xu B, Wang X, Tan B, Zhao J. Intervention of the Nuss Procedure on the Mental Health of Pectus Excavatum Patients. Ann Thorac Cardiovasc Surg. 2017 Aug 20;23(4):175-180. doi: 10.5761/atcs.oa.17-00014. Epub 2017 Jun 16.

  PMID: 28626162 BACKGROUND

• Hadolt B, Wallisch A, Egger JW, Hollwarth ME. Body-image, self-concept and mental exposure in patients with pectus excavatum. Pediatr Surg Int. 2011 Jun;27(6):665-70. doi: 10.1007/s00383-011-2854-z. Epub 2011 Feb 3.

  PMID: 21290134 BACKGROUND

• Ji Y, Liu W, Chen S, Xu B, Tang Y, Wang X, Yang G, Cao L. Assessment of psychosocial functioning and its risk factors in children with pectus excavatum. Health Qual Life Outcomes. 2011 May 4;9:28. doi: 10.1186/1477-7525-9-28.

  PMID: 21542911 BACKGROUND

• Ticchi D, Eisinger RS, Pilegaard HK, Torre M, Sesia SB, Infante M, Voulaz E, Quesada MA, Sisask M. Evaluating interest in narrative therapy for decision making about pectus excavatum treatment. Interact Cardiovasc Thorac Surg. 2018 Feb 1;26(2):271-275. doi: 10.1093/icvts/ivx308.

  PMID: 29049840 BACKGROUND

• Wildemeersch D, Bernaerts L, D'Hondt M, Hans G. Reference Correction: Preliminary Evaluation of a Web-Based Psychological Screening Tool in Adolescents Undergoing Minimally Invasive Pectus Surgery: Single-Center Observational Cohort Study. JMIR Ment Health. 2018 Nov 12;5(4):e11608. doi: 10.2196/11608.

  PMID: 30578210 BACKGROUND

MeSH Terms

Conditions

Funnel Chest; Pectus Carinatum

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martin Rosanna, PsyD

  Meyer Children's Hospital IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 27, 2020
• Study Start: October 8, 2019
• Primary Completion: February 28, 2021
• Study Completion: September 30, 2021
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

IT (1)