NCT07259369

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 17, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

chronic kidney diseasefatigueApppruritusself-acupressuresleep quality

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

EXPERIMENTAL

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

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.

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.

App-based acupressure Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

FatigueRenal Insufficiency, ChronicAlzheimer DiseasePruritusSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

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

Locations