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临床试验/NCT05489003
NCT05489003Unknown不适用

Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
The incidence of anxiety among patients with CP in China.

研究概览

简要总结

This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.

详细描述

Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic fibrosis. Available studies suggested that the incidence of CP in China was about 13.5 per 100,000 people. Patients with CP often have symptoms of pancreatic endocrine and exocrine insufficiency such as elevated blood sugar, weight loss, muscle loss, combined with complications such as pancreatic duct stones, pancreatic duct stenosis, pancreatic pseudocysts, and have a higher risk of pancreatic cancer, which seriously affects the quality of life of patients.

Psychological comorbidities represented by anxiety and depression were thought to be widespread in CP patients, with available epidemiological studies indicating that the prevalence of anxiety and depression in CP patients in the United States was 36.8% and 46.8%, respectively. In addition, fatigue, as a subjective perception of decreased ability to perform physical and/or intellectual tasks, has also been founded among CP patients.

However, to date, there is a lack of epidemiological studies on fatigue, anxiety, depression and quality of life in Chinese patients with CP. This study will investigate the epidemiological status of fatigue, anxiety, depression, and quality of life in Chinese patients with CP and analyze the factors influencing them.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic pancreatitis

排除标准

  • Illiterate
  • Having communication difficulties
  • Unable to complete the questionnaires
  • Having a history of psychiatric disorders
  • Recent history of psychotropic and sedative drug use
  • Pregnancy
  • Rejected participants

结局指标

主要结局

The incidence of anxiety among patients with CP in China.

时间窗: Within 1 month after data analysis.

The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-Rating Anxiety Scale (SAS).

The incidence of depression among patients with CP in China.

时间窗: Within 1 month after data analysis.

The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-rating Depression Scale (SDS).

The incidence of quality of life among patients with CP in China.

时间窗: Within 1 month after data analysis.

The level of quality of life in CP patients is measured using the European organization for the research and treatment of cancer QOL questionnaire (EORTC-QLQ C-30).

The incidence of fatigue among patients with CP in China.

时间窗: Within 1 month after data analysis.

The level of fatigue in CP patients was measured using the Multidimensional Fatigue Inventory (MFI-20), and the Fatigue Severity Scale (FSS).

次要结局

  • The influencing factors of anxiety and depression among patients with CP in China.(Within 1 month after data analysis.)
  • The influencing factors of depression among patients with CP in China.(Within 1 month after data analysis.)
  • The influencing factors of fatigue among patients with CP in China.(Within 1 month after data analysis.)
  • The influencing factors of quality of life among patients with CP in China.(Within 1 month after data analysis.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Professor

Changhai Hospital

研究点 (1)

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