An interventional study of True acupressure and Sham acupressure in End-stage Renal Disease, sponsored by Woung-Ru Tang. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by Woung-Ru Tang · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 116 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
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
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.
Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.
Brief Fatigue Inventory (BFI)
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).
Time frame: Before the intervention (baseline, T0)
Brief Fatigue Inventory (BFI)
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).
Time frame: Completion of the 4-week intervention (post-test, T1)
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Before the intervention (baseline, T0)
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Completion of the 4-week intervention (post-test, T1)
Hospital Anxiety and Depression Scale
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.
Time frame: Before the intervention (baseline, T0)
Hospital Anxiety and Depression Scale
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.
Time frame: Completion of the 4-week intervention (post-test, T1)
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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