Clinical trial NCT05571007: Effect of Acupressure on Fatigue in Hemodialysis Patients
Official title: Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: End-stage renal disease
Hemodialysis
Acupressure
Fatigue
Sleep
Anxiety/depression
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Harapan Bangsa University
name: RS Prof. Dr. Margono Soekardjo Purwokerto
First posted: 2022-10-07
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVE: To investigate the effect of acupressure on fatigue in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD) as well as assess sleep quality and psychological status HYPOTHESIS TO BE TESTED: Upon intervention completion, the experimental group will exhibit lower severity of fatigue and depression/anxiety and improved sleep quality compared to the control group.

DESIGN AND SUBJECTS: A randomized controlled trial with experimental and control groups. A total of 116 patients with ESRD who screen positive for fatigue severity ≥ 4 (using a single-item indicator of fatigue, which ranges from 0 to 10 points) will be recruited.

STUDY INSTRUMENTS: Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS) INTERVENTION: A 4-week acupressure intervention was performed by the principal investigator (PI) for every subject by applying the rate of two rotations per second, three times a week.

MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, depression, and anxiety.

DATA ANALYSIS: Multiple regression was used to analyze between-group differences in BFI and PSQI, while ordinal logistic regression was used to analyze the subscales of the HADS.

EXPECTED RESULTS: The proposed acupressure intervention is useful for alleviating fatigue and related symptoms (sleep quality, depression, and anxiety) experienced by patients with ESRD.

Detailed description: The prevalence and impact of fatigue and related symptoms in patients with ESRD have been clearly demonstrated in the literature, which also emphasizes the need for evidence-based interventions targeting symptom management in such patients. The main challenge is identifying an intervention that is not only effective in managing hemodialysis-related symptoms, but also feasible, acceptable, and safe for this patient group. The proposed study primarily aims to test the effects of acupressure intervention on fatigue in ESRD patients receiving HD using the robust study design of a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≧ 18 years
* 2. HD therapy for at least 3 months
* 3. Experience of fatigue (fatigue severity ≥ 4, using a single-item indicator of fatigue, ranging from 0 to 10 points)
* 4. Absence of lower limb wounds
* 5. Did not receive any complementary treatment

Exclusion Criteria:

* 1. Diagnosis of major depression or psychiatric disorders
* 2. Wound or amputation of the lower extremities, rheumatoid arthritis, or limb fracture

Primary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: Before the intervention (baseline, T0)
measure: Brief Fatigue Inventory (BFI)
timeFrame: Completion of the 4-week intervention (post-test, T1)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Before the intervention (baseline, T0)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Completion of the 4-week intervention (post-test, T1)
measure: Hospital Anxiety and Depression Scale
timeFrame: Before the intervention (baseline, T0)
measure: Hospital Anxiety and Depression Scale
timeFrame: Completion of the 4-week intervention (post-test, T1)
Other outcomes:
Locations:
city: Purwokerto
country: Indonesia
facility: RS Prof Dr Margono Soekardjo Purwokerto
state: Central Java
Study officials:
affiliation: School of Nursing, Harapan Bangsa University, Central Java, Indonesia
name: Made Suandika, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
References: