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Effect of Acupressure on Fatigue in Hemodialysis Patients

W

Woung-Ru Tang

Status

Completed

Conditions

End-stage Renal Disease

Treatments

Other: True acupressure
Other: Sham acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05571007
3010/KEPK/VII/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

116 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

116 participants in 2 patient groups

True acupressure
Experimental group
Description:
Using three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD.
Treatment:
Other: True acupressure
Sham acupressure
Sham Comparator group
Description:
Using three sham acupoints. Acupoints: Sham acupoints are located on 1 cun from the true acupoint. Patient Position: Lying or sitting position. Time: first 2 hours of HD.
Treatment:
Other: Sham acupressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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