Effect of Acupressure on Fatigue in Hemodialysis Patients

Sponsor

Woung-Ru Tang (Other)

Overall Status

Completed

CT.gov ID

NCT05571007

Collaborator

Harapan Bangsa University (Other), RS Prof. Dr. Margono Soekardjo Purwokerto (Other)

116

Enrollment

Location

Arms

Actual Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease	Other: True acupressure Other: Sham acupressure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-blinded Randomized Controlled Trial

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Oct 30, 2019

Actual Study Completion Date :

Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: True acupressure Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.
Sham Comparator: 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.	Other: Sham acupressure Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.

Arm

Intervention/Treatment

Experimental: 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.

Other: True acupressure

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.

Sham Comparator: 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.

Other: Sham acupressure

Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.

Outcome Measures

Primary Outcome Measures

Brief Fatigue Inventory (BFI) [Before the intervention (baseline, T0)]
A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively. The BFI score is classified into mild (1-3 points), moderate (4-6 points), and severe fatigue (7-10 points).
Brief Fatigue Inventory (BFI) [Completion of the 4-week intervention (post-test, T1)]
A questionnaire will be used to measure the severity of fatigue in the past 24 hours. This 9-item self-reported questionnaire is scored on a 0-10 numerical rating scale, where 0 and 10 represent absence and the highest severity of fatigue, respectively. The BFI score is classified into mild (1-3 points), moderate (4-6 points), and severe fatigue (7-10 points).

Secondary Outcome Measures

Pittsburgh Sleep Quality Index (PSQI) [Before the intervention (baseline, T0)]
This 19-item self-reported questionnaire is combined to form seven component scores (subjective sleep quality, latency, duration, habit efficiency, disturbances, medication, and daytime dysfunction). Each of these has a range of 0-3 points added to yield a global score with a range of 0-21. A global score higher than five indicates poor sleep quality.
Pittsburgh Sleep Quality Index (PSQI) [Completion of the 4-week intervention (post-test, T1)]
This 19-item self-reported questionnaire is combined to form seven component scores (subjective sleep quality, latency, duration, habit efficiency, disturbances, medication, and daytime dysfunction). Each of these has a range of 0-3 points added to yield a global score with a range of 0-21. A global score higher than five indicates poor sleep quality.
Hospital Anxiety and Depression Scale [Before the intervention (baseline, T0)]
This 14-item questionnaire will be used to measure psychological status. This 14-item questionnaire has two subscales: anxiety (seven items) and depression (seven items). It is measured on a 4-point Likert scale ranging from 0 (not at all) to 3 (very often), with higher scores indicating an increased level of anxiety/depression. The HADS score is classified as severe (16-21 points), moderate (11-15 points), mild (8-10 points), or no anxiety or depression (≤7 points). It is a valid, trustworthy, and easy measurement tool used by health care providers to identify and quantify anxiety and depression.
Hospital Anxiety and Depression Scale [Completion of the 4-week intervention (post-test, T1)]
This 14-item questionnaire will be used to measure psychological status. This 14-item questionnaire has two subscales: anxiety (seven items) and depression (seven items). It is measured on a 4-point Likert scale ranging from 0 (not at all) to 3 (very often), with higher scores indicating an increased level of anxiety/depression. The HADS score is classified as severe (16-21 points), moderate (11-15 points), mild (8-10 points), or no anxiety or depression (≤7 points). It is a valid, trustworthy, and easy measurement tool used by health care providers to identify and quantify anxiety and depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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