Clinical trial NCT05489003: Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.
Official title: Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Keywords: Chronic pancreatitis
Fatigue
Anxiety
Depression
Quality of life
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pancreatitis in China.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic pancreatitis

Exclusion Criteria:

* 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

Primary outcomes:
measure: The incidence of fatigue among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The incidence of anxiety among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The incidence of depression among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The incidence of quality of life among patients with CP in China.
timeFrame: Within 1 month after data analysis.
Secondary outcomes:
measure: The influencing factors of fatigue among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The influencing factors of anxiety and depression among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The influencing factors of depression among patients with CP in China.
timeFrame: Within 1 month after data analysis.
measure: The influencing factors of quality of life among patients with CP in China.
timeFrame: Within 1 month after data analysis.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Liang-Hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: