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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
研究概览
简要总结
The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of pectus excavatum or pectus carinatum;
- •Age from 12 to 18 years old;
- •High level of fluency in Italian.
排除标准
- •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.
结局指标
主要结局
Differences in mental health mean scores on the Youth Self-Report (YSR) between PE and PC patients.
时间窗: 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.
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients in different age ranges.
时间窗: 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.
Differences in mental health mean scores on the Youth Self-Report (YSR) among patients with different severity indexes.
时间窗: 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.
Correlation between mental health scores on the Child Behavior Checklist (CBCL) and mental health scores on the Youth Self-Report (YSR).
时间窗: 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.
次要结局
- 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.)
- 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).(Baseline.)
- Differences in body image mean scores on the Body Uneasiness Test (BUT) among patients in different age ranges.(Baseline.)
- Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) between PE and PC patients.(Baseline.)
- Correlation among self-esteem scores on the Rosenberg Self-Esteem Scale (RSES) and mental health scores on the Youth Self-Report (YSR).(Baseline.)
- Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) 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.)
- Correlation between scores on Pediatric Quality of Life Inventory (parent version) and scores on Pediatric Quality of Life Inventory (early-adolescent and adolescent versions).(One only time point, immediately after the medical examination, that requires 10 minutes for questionnaire completion.)
- Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients with different severity indexes.(Baseline.)
- Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) between PE and PC patients.(Baseline.)
- Differences in self-esteem mean scores on the Rosenberg Self-Esteem Scale (RSES) among patients in different age ranges.(Baseline.)
- Differences in quality of life mean scores on the Pediatric Quality of life Inventory (Peds-Ql) among patients with different severity indexes.(Baseline.)
研究者
Daniela Graziani
Principal Investigator
University of Florence