跳至主要内容
临床试验/NCT06270277
NCT06270277已完成不适用

Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease: Prospective Controlled Trial

Sisli Hamidiye Etfal Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 159 人开始时间: 2024年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
159
试验地点
2
主要终点
Strengths and Difficulties Questionnaire (SDQ)

研究概览

简要总结

Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 8-17 years
  • Diagnosed Inflammatory bowel disease
  • Healthy adolescents aged between 8-17 years

排除标准

  • Not obtaining informed consent
  • Diagnosis of psychiatric disorder

研究组 & 干预措施

Control group

Active Comparator

Adolescents without known diseases in same age group will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ) as control group

干预措施: Strengths and Difficulties Questionnaire (SDQ) (Diagnostic Test)

Inflammatory bowel disease group

Experimental

Adolescents with Inflammatory bowel diseases will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).

干预措施: Pediatric Quality of Life Inventory (PedsQL) (Diagnostic Test)

Inflammatory bowel disease group

Experimental

Adolescents with Inflammatory bowel diseases will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).

干预措施: Strengths and Difficulties Questionnaire (SDQ) (Diagnostic Test)

Control group

Active Comparator

Adolescents without known diseases in same age group will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ) as control group

干预措施: Pediatric Quality of Life Inventory (PedsQL) (Diagnostic Test)

结局指标

主要结局

Strengths and Difficulties Questionnaire (SDQ)

时间窗: 1 day after questionnaire

Score of questionnaire

Pediatric Quality of Life Inventory (PedsQL) score

时间窗: 1 day after questionnaire

Score of questionnaire

次要结局

未报告次要终点

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Tetik Dincer

Principal investigator

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (2)

Loading locations...

相似试验