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NCT Number: NCT05571007

Effect of Acupressure on Fatigue in Hemodialysis Patients

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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Key information

Conditions

End-stage Renal Disease Anxiety Disorders Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RS Prof Dr Margono Soekardjo Purwokerto

Purwokerto, Central Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

True acupressure

Other

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

Total time: 18 minutes/acupressure therapy.

Sham acupressure

Other

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

Total time: 18 minutes/acupressure therapy.

Primary outcomes

  1. Brief Fatigue Inventory (BFI)

    Time frame: 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).

  2. Brief Fatigue Inventory (BFI)

    Time frame: 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 outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. Hospital Anxiety and Depression Scale

    Time frame: 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.

  4. Hospital Anxiety and Depression Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woung-Ru Tang

Other

Collaborators

  • Harapan Bangsa University
  • RS Prof. Dr. Margono Soekardjo Purwokerto

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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