Can ear acupressure help people with severe liver disease sleep better?

ISRCTN	ISRCTN74827499
DOI	https://doi.org/10.1186/ISRCTN74827499
Sponsor	Beijing You'an Hospital Affiliated to Capital Medical University
Funder	Investigator initiated and funded

Submission date: 17/11/2025
Registration date: 19/11/2025
Last edited: 18/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Feifei Liu
Principal investigator, Public, Scientific

No. 8, Xitoutiao, You'anmenwai, Fengtai District
Beijing
100069
China

ORCID ID	0009-0001-3268-2419
Phone	+86 13811638909
Email	liufeifei_ff@126.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Supportive care, Treatment
Scientific title	Auricular acupressure for insomnia in patients with decompensated hepatitis B-related liver cirrhosis
Study objectives	This study is conducted to evaluate the efficacy and safety of auricular acupressure for insomnia in patients with decompensated hepatitis B-related liver cirrhosis (DHBV-LC). Our aim was to provide evidence-based support for insomnia management in this population.
Ethics approval(s)	Approved 14/12/2023, Ethics Committee of Beijing You'an Hospital Affiliated to Capital Medical University (No. 8, Xitoutiao, You'anmenwai, Fengtai District, Beijing, 100069, China; +86 01083997028; youanlunli@126.com), ref: JYKLY[2023]343
Health condition(s) or problem(s) studied	Treatment of insomnia in patients with decompensated hepatitis B-related liver cirrhosis
Intervention	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 sealed in opaque envelopes. After enrollment, the research nurse opened the envelope corresponding to the patient’s sequence number to determine group allocation. Although the application of auricular acupressure beads makes blinding of patients and treating clinicians unfeasible, outcome assessors and data analysts remained blinded to group allocation throughout the study. Interventions The control group received standard therapy based on the Chinese Guideline for the Diagnosis and Treatment of Insomnia in Adults, including sleep hygiene education and psychological counseling. Sleep hygiene education emphasized maintaining a regular sleep-wake schedule; 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 insomnia. The intervention group received auricular acupressure in addition to standard therapy. Acupoints were selected with reference to the WHO Standard Acupuncture Point Locations and preceding research, including Shenmen (HT7), Heart, Spleen, Sympathetic, and Subcortex. The procedure was as follows: after routine disinfection of the auricle with 75% alcohol, vaccaria seeds (Semen Vaccariae) were affixed to the designated acupoints. According to the midnight-noon ebb-flow theory ("Zi Wu Liu Zhu" in Chinese) of traditional Chinese medicine, acupressure was performed between 9:00 a.m. and 11:00 a.m. (Spleen meridian peak) and 11:00–13:00 p.m. (Heart meridian peak). Each acupoint was pressed for 30–60 seconds until the patient experienced sensations of soreness, numbness, distension, or mild warmth. Patients were instructed to press the seeds five times daily. Treatment was administered for 5 consecutive days each week, followed by a 2-day rest, constituting one treatment cycle. A total of 4 cycles (4 weeks) were completed.
Intervention type	Other
Primary outcome measure(s)	Sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of hypnotic medications, and daytime dysfunction measured using Pittsburgh Sleep Quality Index (PSQI) at baseline (within 24 hours before enrolment), week 2, and week 4 (end of treatment)
Key secondary outcome measure(s)	Insomnia severity measured using Insomnia Severity Index (ISI) at baseline(within 24 hours before enrollment), week 2, and week 4 (end of treatment) Irritability with insomnia, frequent dreaming or easy awakening, palpitations with poor memory, dizziness, mental fatigue, and poor appetite with abdominal distension measured using traditional Chinese medicine (TCM) syndrome score at baseline(within 24 hours before enrollment), week 2, and week 4 (end of treatment)
Completion date	30/07/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key 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
Key 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
Date of first enrolment	16/05/2023
Date of final enrolment	28/06/2024

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

17/11/2025: Trial's existence confirmed by Ethics Committee of Beijing You'an Hospital Affiliated to Capital Medical University.