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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05571007
Study type Interventional
Source Chang Gung University
Contact
Status Completed
Phase N/A
Start date July 1, 2019
Completion date November 30, 2019

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