An interventional study of app-based acupressure in Hemodialysis Patient and Fatigue, sponsored by Taipei Medical University. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care
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.
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's enrollment of 60 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: The patients are
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks.
Device: app-based acupressure
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.
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.
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.
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)).
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.
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
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.
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)).
Excluded (n=85) due to: Assessed for eligibility (n=145) NRS \<4 (n=42) Cancer (n=1) Cognitive impairment (n=2) Edema (n=3) Unable to communicate (n=1) Previous use of acupressure (n=2) Refuse to participate (n=33) Using another intervention (n=1)
| Milestone | App-based Acupressure Group | Control Group |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 26 |
| Not completed | 1 | 4 |
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.
| score | App-based Acupressure Group | Control Group |
|---|---|---|
| Baseline (T1) | 34.03 ± 1.87 | 33.20 ± 2.45 |
| T2 | 27.03 ± 2.06 | 32.52 ± 2.10 |
| T3 | 25.81 ± 1.89 | 32.17 ± 2.48 |
| T4 | 29.22 ± 2.52 | 30.47 ± 2.10 |
| T5 | 27.56 ± 2.39 | 28.34 ± 2.26 |
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.
| score | App-based Acupressure Group | Control Group |
|---|---|---|
| Baseline (T1) | 7.47 ± 0.81 | 8.30 ± 0.72 |
| T2 | 6.89 ± 0.50 | 7.67 ± 0.59 |
| T3 | 6.91 ± 0.46 | 7.11 ± 0.49 |
| T4 | 8.04 ± 0.70 | 8.20 ± 0.71 |
| T5 | 8.14 ± 0.66 | 8.17 ± 0.60 |
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.
| score | App-based Acupressure Group | Control Group |
|---|---|---|
| Baseline (T1) | 6.87 ± 0.74 | 7.07 ± 0.63 |
| T2 | 6.06 ± 0.71 | 6.08 ± 0.69 |
| T3 | 5.23 ± 0.70 | 6.63 ± 0.69 |
| T4 | 6.62 ± 0.84 | 6.97 ± 0.66 |
| T5 | 6.08 ± 0.77 | 7.47 ± 0.66 |
Collected over From enrollment until the end of the 8-week follow-up (up to 12 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| App-based Acupressure Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(year) | Intervention Group | Control | Total |
|---|---|---|---|
| Mean | 46.63 ± 12.48 | 50.03 ± 10.82 | 48.33 ± 11.71 |
| Sex/Gender, Customized(Participants) | Intervention Group | Control | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 16 | 19 | 35 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Intervention Group | Control | Total |
|---|---|---|---|
| Vietnam | 30 | 30 | 60 |
| duration of dialysis(month) | Intervention Group | Control | Total |
|---|---|---|---|
| Mean | 134.20 ± 88.95 | 79.43 ± 65.11 | 106.82 ± 82.07 |
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.