End-stage Renal DiseaseNCT05571007
Effect of Acupressure on Fatigue in Hemodialysis Patients
A study testing True acupressure in people with End-stage Renal Disease, run by Woung-Ru Tang at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- True acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Diagnosis of major depression or psychiatric disorders
- 2. Wound or amputation of the lower extremities, rheumatoid arthritis, or limb fracture
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RS Prof Dr Margono Soekardjo Purwokerto
Purwokerto, Central Java
About this study
Official title: Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-blinded Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- True acupressure, Sham acupressure
- Keywords
- End-stage renal disease, Hemodialysis, Acupressure, Fatigue, Sleep, Anxiety/depression
- Medical subject headings
- Kidney Failure, Chronic, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True acupressureOther
Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).
Total time: 18 minutes/acupressure therapy.
Sham acupressureOther
Duration: 3 minutes for each acupoint, applied bilaterally (right and left sides).
Total time: 18 minutes/acupressure therapy.
| Study group | Role | What they receive |
|---|---|---|
| True acupressure | Experimental | Using three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD. Receives: Other: True acupressure |
| Sham acupressure | Sham comparator | 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. Receives: Other: Sham acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Completion of the 4-week intervention (post-test, T1)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Completion of the 4-week intervention (post-test, T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jul 2019
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woung-Ru Tang
- Sponsor type
- University, hospital or other
- Collaborators
- Harapan Bangsa University, RS Prof. Dr. Margono Soekardjo Purwokerto
- Responsible party
- Sponsor-investigator, Woung-Ru Tang, Chang Gung University
- Investigators
- Made Suandika, PhDCandidate, Principal investigator, School of Nursing, Harapan Bangsa University, Central Java, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571007
- Sponsor's protocol ID
- 3010/KEPK/VII/2019
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suandika M, Chen SY, Fang JT, Yang SH, Tsai YF, Weng LC, Tsay PK, Tang WR. Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-Blinded Randomized Controlled Trial. J Integr Complement Med. 2023 Feb;29(2):111-118. doi: 10.1089/jicm.2022.0644. Epub 2022 Nov 22.
PubMed 36413013
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05571007
- Acronym / sponsor ID
- 3010/KEPK/VII/2019
- Conditions
- End-stage Renal Disease
- Keywords
- End-stage renal disease, Hemodialysis, Acupressure, Fatigue, Sleep, Anxiety/depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Woung-Ru TangUniversity, hospital or other
- Collaborators
- Harapan Bangsa University, RS Prof. Dr. Margono Soekardjo Purwokerto
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True acupressure | Experimental | Other: True acupressureUsing three true acupoints. Acupoints: Yongquan (K1), Sayingjiao (SP6), Zusanli (ST36). Patient Position: Lying or sitting position. Time: first 2 hours of HD. |
| Sham acupressure | Sham comparator | Other: Sham acupressureUsing 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 1. Diagnosis of major depression or psychiatric disorders
- 2. Wound or amputation of the lower extremities, rheumatoid arthritis, or limb fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True acupressureDuration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy. | Other | True acupressure |
| Sham acupressureDuration: 3 minutes for each acupoint, applied bilaterally (right and left sides). Total time: 18 minutes/acupressure therapy. | Other | Sham acupressure |
Primary outcome
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).
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).
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Before the intervention (baseline, T0)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Completion of the 4-week intervention (post-test, T1)
Hospital Anxiety and Depression Scale
Time frame: Before the intervention (baseline, T0)
Hospital Anxiety and Depression Scale
Time frame: Completion of the 4-week intervention (post-test, T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Derived from this study: PubMed 36413013Suandika M, Chen SY, Fang JT, Yang SH, Tsai YF, Weng LC, Tsay PK, Tang WR. Effect of Acupressure on Fatigue in Hemodialysis Patients: A Single-Blinded Randomized Controlled Trial. J Integr Complement Med. 2023 Feb;29(2):111-118. doi: 10.1089/jicm.2022.0644. Epub 2022 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Made Suandika, PhDCandidate principal investigator
School of Nursing, Harapan Bangsa University, Central Java, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True acupressure in people with End-stage Renal Disease, run by Woung-Ru Tang at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory (BFI) (time frame: Before the intervention (baseline, T0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.