Clinical trial NCT04362878: Psychological Assessment of Patients With Chest Wall Deformities
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Excavatum
Pectus Carinatum
Keywords: Pectus excavatum
Pectus carinatum
Adolescents
Psychological Assessment
Quality of life
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Meyer Children's Hospital IRCCS
First posted: 2020-04-27
Enrollment: 209
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.
timeFrame: Baseline.
measure: Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
timeFrame: Baseline
measure: Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.
timeFrame: Baseline
measure: Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).
timeFrame: Baseline.
Secondary outcomes:
measure: Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients with different severity indexes.
timeFrame: Baseline.
measure: Differences in body image mean scores on the Body Uneasiness Test (BUT) between PE and PC patients.
timeFrame: Baseline.
measure: Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.
timeFrame: Baseline.
measure: Correlation among body image scores on the Body Uneasiness Test (BUT) and mental health scores on the Youth Self-Report (YSR).
timeFrame: Baseline.
measure: Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.
timeFrame: Baseline.
measure: Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.
timeFrame: Baseline.
measure: Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.
timeFrame: Baseline.
measure: Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).
timeFrame: Baseline.
measure: Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.
timeFrame: Baseline.
measure: Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.
timeFrame: Baseline.
measure: Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients in different age ranges.
timeFrame: Baseline.
measure: 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).
timeFrame: Baseline.
measure: Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).
timeFrame: One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.
Other outcomes:
measure: Degree of the severity of malformation rated on a six-point classification.
timeFrame: Baseline.
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Martin Rosanna, PsyD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.