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Effect of Acupressure on Fatigue in Hemodialysis Patients

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
True acupressure
Sham acupressure
Sponsored by
Woung-Ru Tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring End-stage renal disease, Hemodialysis, Acupressure, Fatigue, Sleep, Anxiety/depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RS Prof Dr Margono Soekardjo Purwokerto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

True acupressure

Sham acupressure

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 30, 2022
Last Updated
October 5, 2022
Sponsor
Woung-Ru Tang
Collaborators
Harapan Bangsa University, RS Prof. Dr. Margono Soekardjo Purwokerto
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1. Study Identification

Unique Protocol Identification Number
NCT05571007
Brief Title
Effect of Acupressure on Fatigue in Hemodialysis Patients
Official Title
Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Woung-Ru Tang
Collaborators
Harapan Bangsa University, RS Prof. Dr. Margono Soekardjo Purwokerto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
End-stage renal disease, Hemodialysis, Acupressure, Fatigue, Sleep, Anxiety/depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True acupressure
Arm Type
Experimental
Arm Description
Using three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD.
Arm Title
Sham acupressure
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
True acupressure
Intervention Description
Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.
Intervention Type
Other
Intervention Name(s)
Sham acupressure
Intervention Description
Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy.
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory (BFI)
Description
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)
Title
Brief Fatigue Inventory (BFI)
Description
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)
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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)
Title
Hospital Anxiety and Depression Scale
Description
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)
Title
Hospital Anxiety and Depression Scale
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Made Suandika, PhDCandidate
Organizational Affiliation
School of Nursing, Harapan Bangsa University, Central Java, Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
RS Prof Dr Margono Soekardjo Purwokerto
City
Purwokerto
State/Province
Central Java
Country
Indonesia

12. IPD Sharing Statement

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Effect of Acupressure on Fatigue in Hemodialysis Patients

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