The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
1 other identifier
interventional
70
1 country
1
Brief 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. 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 (PDF), 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 (GEE) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 2, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2026
CompletedDecember 2, 2025
November 1, 2025
3 months
November 17, 2025
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 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
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)).
Study Arms (2)
App-based acupressure Group
EXPERIMENTALThe 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 INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hoe Nhai General Hospital
Hanoi, Hong Ha, 100000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
November 17, 2025
First Posted
December 2, 2025
Study Start
December 15, 2025
Primary Completion
March 15, 2026
Study Completion
March 15, 2026
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share