Effect of Acupressure on Fatigue in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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True acupressure

Using three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD.

Group Type EXPERIMENTAL

True acupressure

Intervention Type OTHER

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).

Total time: 18 minutes/acupressure therapy.

Sham acupressure

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.

Group Type SHAM_COMPARATOR

Sham acupressure

Intervention Type OTHER

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).

Total time: 18 minutes/acupressure therapy.

Interventions

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True acupressure

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).

Total time: 18 minutes/acupressure therapy.

Intervention Type OTHER

Sham acupressure

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).

Total time: 18 minutes/acupressure therapy.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No