Treatment of insomnia in patients with decompensated hepatitis B-related liver cirrhosis Digestive System
Conditions
Interventions
Randomization and Blinding
Block randomization with a block size of 4 was generated using a computer-based random number table. The randomization scheme was prepared by an independent statistician and
avoiding stimulants such as coffee, strong tea, tobacco, and alcohol before bedtime
refraining from vigorous exercise and heavy meals in the evening
creating a comfortable sleep environment (temperature 18–22°C, humidity 50%–60%)
and practicing relaxation techniques before sleep. Psychological counseling focused on helping patients develop realistic expectations regarding sleep and reducing excessive preoccupation with insomni
Sponsors
Beijing You'an Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years 2. Fulfillment of both the diagnostic criteria for insomnia and decompensated cirrhosis: the diagnostic criteria for insomnia included difficulty initiating sleep (sleep latency >30 min), difficulty maintaining sleep (=2 awakenings per night), early morning awakening, reduced total sleep duration (usually <6.5 h), and poor subjective sleep quality, accompanied by daytime functional impairment. The presence of liver cirrhosis complicated by portal hypertension-related events such as ascites, variceal hemorrhage, or hepatic encephalopathy 3. Pittsburgh Sleep Quality Index (PSQI) score =7 4. No insomnia-related treatment within the past month 5. Voluntary participation with signed informed consent
Exclusion criteria
Exclusion criteria: 1. Secondary insomnia attributable to other causes (e.g. pain, dyspnea) 2. Auricular skin damage, ulceration, or other conditions precluding acupoint intervention 3. History of life-threatening comorbidities such as acute myocardial infarction, stroke, or malignancy; severe psychiatric or psychological disorders 4. Allergy-prone individuals or those with hypersensitivity to study materials; pregnancy or lactation 5. Participation in another clinical trial within the previous three months
Countries
China
Contacts
Public ContactFeifei Liu
Outcome results
None listed