Hemodialysis PatientNCT07259369
The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
A study testing app-based acupressure in people with Hemodialysis Patient and Fatigue, run by Taipei Medical University at 1 site in Vietnam.
Trial summary
Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients. Design and subjects: The parallel randomized controlled trial will be employed in one hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patient, Fatigue
- What is being tested?
- app-based acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Dec 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or over
- are able to speak and understand Vietnamese,
- receive hemodialysis at least three times a week for three months or longer
- have a score equal to or greater than 4 on a numeric rating scale (NRS, 0-10)
- has a smartphone or tablet
- can provide written informed consent. Exclusion Criteria: The patients who have
Show all 12Show fewer
- advanced cancer
- cognitive impairment
- chronic obstructive pulmonary disease
- severe edema
- have already used or plan to use acupressure or acupuncture in the following 3 months
- have soft tissue or vascular disease in their lower extremities
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an App-based Acupressure Intervention on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients.
Design and subjects: The parallel randomized controlled trial will be employed in one hospital. Block randomization in a 1:1 ratio will be used to assign the patients to the intervention and control groups. It is estimated that 50 to 100 participants receiving hemodialysis will be recruited.
Read more
Instrument: The demographic and health-related information questionnaire, the Post-dialysis Fatigue, 5-D Itch, and Pittsburgh Sleep Quality Index will be used in this study.
Interventions: The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. Participants in the control group will receive usual care and no other intervention.
Data analysis: Both intention-to-treat and per-protocol analysis approaches will be performed. Generalized Estimating Equations analysis will be used to assess the effectiveness of the interventions. Sensitivity analysis will be conducted to assess the impact of missing data on the treatment effect if necessary.
Expected outcomes: Participants in the intervention group will know how to do the self-guided acupressure by themselves. If the intervention is effective, the App can be introduced to the hemodialysis patients who need it.
Read the detailed description
Fatigue is one of the most common and distressing symptoms among hemodialysis patients, negatively affecting physical function, psychological well-being, and quality of life. Current pharmacological and non-pharmacological interventions show inconsistent effectiveness, highlighting the need for alternative symptom management strategies. Acupressure, a non-invasive therapy from traditional Chinese medicine, has shown potential in reducing fatigue and improving related symptoms. Self-administered acupressure is simple, low-cost, and suitable for long-term self-care. At the same time, mobile health applications have become increasingly useful for supporting self-management in chronic diseases through reminders, education, and personalized feedback.
This study aims to evaluate the effectiveness of an app-based self-guided acupressure intervention in reducing fatigue among HD patients, as well as its effects on pruritus and sleep quality. The intervention is based on Bandura's Social Cognitive Theory, particularly the concept of self-efficacy. The app includes instructional videos, reminder notifications, motivational messages, and self-monitoring functions to encourage regular practice and improve confidence in symptom management.
A two-arm parallel randomized controlled trial will be conducted at the hemodialysis unit of Hoe Nhai Hospital, Hanoi, Vietnam. Eligible participants are HD patients aged 18 years or older with moderate fatigue levels and smartphone access. Approximately 50-100 participants will be recruited and randomly assigned to either the intervention or usual care group.
Participants in the intervention group will use the AcuCare mobile application to perform daily self-acupressure for four weeks. The app provides guidance for stimulating four acupoints: SP6, KI1, ST36, and GV29. Reminder notifications and motivational feedback will support adherence. Outcomes, including fatigue, pruritus, sleep quality, and comfort, will be assessed at baseline, during intervention, immediately post-intervention, and follow-up periods.
Data will be analyzed using SPSS and Generalized Estimating Equations. Ethical approval will be obtained from the Institutional Review Board of Hanoi University of Public Health, and written informed consent will be collected from all participants.
- Conditions
- Hemodialysis Patient, Fatigue
- Being tested
- app-based acupressure
- Keywords
- chronic kidney disease, fatigue, App, pruritus, self-acupressure, sleep quality
- Medical subject headings
- Fatigue, Renal Insufficiency, Chronic, Alzheimer Disease, Pruritus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app-based acupressureDevice
The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. The app is structured into two main modules: Introduction and Practice. The Introduction section provides basic information about acupressure, including its definition, health benefits, and important safety considerations. This content is delivered through text, photos, and video to support different learning preferences.
| Study group | Role | What they receive |
|---|---|---|
| App-based acupressure Group | Experimental | The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. Receives: Device: app-based acupressure |
| Control group | No intervention | Participants in the control group will receive usual care and no other intervention. After completing the 12-week study, they will be granted free access to the application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be measured by Post-dialysis fatigue (PDF) scale. This scale comprises 13 self-reported items rated on a five-point Likert scale, ranging from 1 (strongly agree) to 5 (not at all). The score will be reversed for analysis, and the total score is between 13 and 65, with higher scores indicating more severe fatigue. Generalized Estimating Equations (GEE) analysis was used to assess differences over time between groups and to adjust for potential covariates.
Measured: Fatigue will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).
Secondary outcomes (2)
Pruritus
Pruritus will be measured by the 5-D Itch scale to evaluate the severity of skin itching conditions over the past 2 weeks based on five dimensions: duration, degree, direction, disability, and distribution. Itching at up to two sites receives a score of 1; three to five sites are assigned a score of 2; the score is 3 for six to ten sites; 11 to 13 sites are scored 4; and the highest score of 5 is given for 14 to 16 sites. The total scores range from 5 to 25. Higher scores indicate greater itch severity.
Measured: Pruritus will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5))
Sleep Quality
Sleep quality will be measured by Pittsburgh Sleep Quality Index. The PSQI was developed by Buysse et al. (1989) consists of 7 components, 3 factors, and 19 subitems, and aims to evaluate a person's sleep quality within the last month, including seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication and (7) daytime dysfunction. Component scores range from 0 (no difficulty) to 3 (severe difficulty). The total score ranges from 0 to 21, with higher values indicating poor sleep quality. A score of more than 5 indicated a person had poor quality sleep.
Measured: Outcome will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start15 Dec 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemodialysis PatientStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN THI THUY NGA, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259369
- Sponsor's protocol ID
- 025-462/DD-YTCC
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an App-based Acupressure Intervention on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07259369
- Acronym / sponsor ID
- 025-462/DD-YTCC
- Conditions
- Hemodialysis Patient, Fatigue
- Keywords
- chronic kidney disease, fatigue, App, pruritus, self-acupressure, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients.
Design and subjects: The parallel randomized controlled trial will be employed in one hospital. Block randomization in a 1:1 ratio will be used to assign the patients to the intervention and control groups. It is estimated that 50 to 100 participants receiving hemodialysis will be recruited.
Instrument: The demographic and health-related information questionnaire, the Post-dialysis Fatigue, 5-D Itch, and Pittsburgh Sleep Quality Index will be used in this study.
Interventions: The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. Participants in the control group will receive usual care and no other intervention.
Data analysis: Both intention-to-treat and per-protocol analysis approaches will be performed. Generalized Estimating Equations analysis will be used to assess the effectiveness of the interventions. Sensitivity analysis will be conducted to assess the impact of missing data on the treatment effect if necessary.
Expected outcomes: Participants in the intervention group will know how to do the self-guided acupressure by themselves. If the intervention is effective, the App can be introduced to the hemodialysis patients who need it.
Detailed description
Fatigue is one of the most common and distressing symptoms among hemodialysis patients, negatively affecting physical function, psychological well-being, and quality of life. Current pharmacological and non-pharmacological interventions show inconsistent effectiveness, highlighting the need for alternative symptom management strategies. Acupressure, a non-invasive therapy from traditional Chinese medicine, has shown potential in reducing fatigue and improving related symptoms. Self-administered acupressure is simple, low-cost, and suitable for long-term self-care. At the same time, mobile health applications have become increasingly useful for supporting self-management in chronic diseases through reminders, education, and personalized feedback.
This study aims to evaluate the effectiveness of an app-based self-guided acupressure intervention in reducing fatigue among HD patients, as well as its effects on pruritus and sleep quality. The intervention is based on Bandura's Social Cognitive Theory, particularly the concept of self-efficacy. The app includes instructional videos, reminder notifications, motivational messages, and self-monitoring functions to encourage regular practice and improve confidence in symptom management.
A two-arm parallel randomized controlled trial will be conducted at the hemodialysis unit of Hoe Nhai Hospital, Hanoi, Vietnam. Eligible participants are HD patients aged 18 years or older with moderate fatigue levels and smartphone access. Approximately 50-100 participants will be recruited and randomly assigned to either the intervention or usual care group.
Participants in the intervention group will use the AcuCare mobile application to perform daily self-acupressure for four weeks. The app provides guidance for stimulating four acupoints: SP6, KI1, ST36, and GV29. Reminder notifications and motivational feedback will support adherence. Outcomes, including fatigue, pruritus, sleep quality, and comfort, will be assessed at baseline, during intervention, immediately post-intervention, and follow-up periods.
Data will be analyzed using SPSS and Generalized Estimating Equations. Ethical approval will be obtained from the Institutional Review Board of Hanoi University of Public Health, and written informed consent will be collected from all participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based acupressure Group | Experimental | Device: app-based acupressureThe intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. |
| Control group | No intervention | –Participants in the control group will receive usual care and no other intervention. After completing the 12-week study, they will be granted free access to the application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years old or over
- are able to speak and understand Vietnamese,
- receive hemodialysis at least three times a week for three months or longer
- have a score equal to or greater than 4 on a numeric rating scale (NRS, 0-10)
- has a smartphone or tablet
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| app-based acupressureThe intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. The app is structured into two main modules: Introduction and Practice. The Introduction section provides basic information about acupressure, including its definition, health benefits, and important safety considerations. This content is delivered through text, photos, and video to support different learning preferences. | Device | App-based acupressure Group |
Primary outcome
Fatigue
Time frame: Fatigue will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).
Fatigue will be measured by Post-dialysis fatigue (PDF) scale. This scale comprises 13 self-reported items rated on a five-point Likert scale, ranging from 1 (strongly agree) to 5 (not at all). The score will be reversed for analysis, and the total score is between 13 and 65, with higher scores indicating more severe fatigue. Generalized Estimating Equations (GEE) analysis was used to assess differences over time between groups and to adjust for potential covariates.
2 secondary outcomes
Pruritus
Time frame: Pruritus will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5))
Sleep Quality
Time frame: Outcome will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing app-based acupressure in people with Hemodialysis Patient and Fatigue, run by Taipei Medical University at 1 site in Vietnam.
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 12 inclusion and 0 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 29 Oct 2026. 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 Vietnam. 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. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fatigue (time frame: Fatigue will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.