The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients (NCT07259369), a randomized na study. The primary outcome is Fatigue.

2. Clinical Question

The study is a parallel randomized controlled trial with a stated 1:1 allocation. Its central comparison concerns fatigue measured at baseline, during the intervention, immediately after it, and during follow-up. The record describes generalized estimating equations as the method for assessing differences over time between groups while adjusting for potential covariates.

The clinical question is about comparative changes in measured outcomes, not simply whether participants can learn to use the app. The brief summary also identifies that learning as an expected outcome, but it does not list it as a measured primary endpoint. Without posted outcome analyses, the registry record does not establish the direction or size of any group difference in fatigue, pruritus, or sleep quality.

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group trial. It lists an enrollment of 60 and a randomized allocation, with the brief summary describing a 1:1 assignment to the intervention and control groups. Block randomization is specified in the summary. The record does not state who was masked, so the meaning of “single-masked” for participants, care providers, or outcome assessors is not reported in the registry record.

The intervention is app-based self-guided acupressure performed once daily for 4 weeks. The comparator is usual care without another intervention during the study; the control group is described as receiving free application access after completing the 12-week study. The primary fatigue assessment is scheduled at baseline, 2 weeks during intervention, immediately after intervention, 4 weeks after intervention, and 8 weeks after intervention. The registry record does not provide calendar dates for these assessment visits.

The brief summary describes both intention-to-treat and per-protocol analyses and says generalized estimating equations will be used. It also describes a sensitivity analysis for missing data if necessary. These are statements about the proposed analytic approach; the record lists zero analyses, so it does not provide resulting estimates or show which analyses were carried out.

The record identifies fatigue as the primary outcome and pruritus and sleep quality as secondary outcomes. It does not report a sample-size justification or the basis for choosing enrollment. The enrollment estimate in the summary is a range of 50 to 100 participants, while the registry record lists an enrollment of 60. These entries describe the trial record and its summary; they do not establish whether all planned procedures were completed as described.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: There are no any significant events that occurred between the enrollment and assignment of participants to an arm or group.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Fatigue, measured over 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))..

The primary endpoint is fatigue measured with the Post-dialysis Fatigue scale. It comprises 13 self-reported items rated on a five-point Likert scale, from 1, “strongly agree,” to 5, “not at all.” The score is reversed for analysis, and the total ranges from 13 to 65. Higher total scores indicate more severe fatigue.

Fatigue is assessed at baseline, 2 weeks during intervention, immediately after intervention, 4 weeks after intervention, and 8 weeks after intervention. Repeated assessment can describe both the course of scores over time and whether the pattern differs between groups. The registry description says generalized estimating equations were used to assess differences over time between groups and adjust for potential covariates.

Using a defined scale gives the outcome a consistent measurement approach across participants and assessment occasions. The five assessment points also distinguish the intervention period from follow-up. They do not, on their own, indicate that fatigue improved or that any group difference was meaningful. No group means, standard deviations, model estimates, confidence intervals, or test results for this endpoint are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group design. Random allocation is intended to create groups that are comparable on average with respect to both measured and unmeasured characteristics, although randomization does not guarantee exact balance in a particular trial. A parallel design assigns participants to one group for the comparison rather than having each participant receive both study conditions. The record states that block randomization and 1:1 allocation will be used. The details of the blocks and the sequence-generation and concealment procedures are not reported in the registry record.

What does a repeated-measures analysis address?

Fatigue is assessed on multiple occasions for each participant. Measurements from the same person are generally related, so treating every measurement as if it came from an unrelated person can misrepresent the uncertainty. A repeated-measures model accounts for that within-person dependence while estimating patterns across the assessment schedule. The registry description specifies generalized estimating equations (GEE) to assess differences over time between groups and adjust for potential covariates.

In general, GEE estimates population-average relationships while accounting for correlation among repeated observations. Its uncertainty estimates depend on the model specification and estimation choices. The registry record does not report the working correlation structure, covariates, link or distribution choices, robust variance procedure, or the exact contrast used to summarize group differences. As a result, the stated method gives a broad outline, not enough detail to reproduce the analysis.

Why can over-dispersion matter?

In general, over-dispersion describes greater variability in data than a statistical model assumes. When it is relevant, standard errors based on an inadequate variance assumption may be too small or too large, affecting confidence intervals and tests. The primary outcome is described as a continuous score, but the record does not identify a distributional assumption or report a diagnostic assessment. Over-dispersion is therefore a general methodological consideration, not a reported finding about this trial.

How should score direction be read?

The Post-dialysis Fatigue scale has 13 self-reported items, each rated on a five-point Likert scale. The description says the score is reversed for analysis, and that higher total scores, from 13 to 65, indicate more severe fatigue. Thus, the scale’s stated direction should be kept in mind when interpreting any future group means or model estimates. The record does not include those results, so no direction of change can be described.

What do planning illustrations mean?

In general, sample-size calculations use assumptions about the effect to be detected, variability, significance level, allocation, and desired power. The record describes planning illustrations based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are not the trial’s original design justification unless the record says they were used to plan the study; no such justification is reported. A calculation based on an observed effect is not observed power, and it cannot replace estimates and uncertainty from the outcome analysis.

The record gives an enrollment of 60 and separately describes an estimated recruitment range of 50 to 100 participants. It does not report a formal sample-size rationale or the assumed effect size and variability used in a prospective design calculation. The registry record also does not give enough output to assess whether the stated analytic approach was implemented as planned.

10. Multiplicity, Missing Data and Analysis Populations

The record identifies fatigue as the primary outcome and pruritus and sleep quality as secondary outcomes. Fatigue is assessed at five time points. Multiple outcomes and repeated assessment occasions create choices about which comparisons are emphasized and how the chance of false-positive findings is handled across analyses. The registry record does not report a multiplicity adjustment strategy, a hierarchy among time-point contrasts, or a single summary contrast intended to represent the primary comparison.

The record’s description of the primary outcome notes several categories or time points and does not reduce them to one comparison. This makes it especially important for results reporting to identify the estimand, contrast, and time point or pattern being interpreted. No such estimates are posted. It is not possible to assess how multiplicity was handled in the analyses or whether any reported inference was adjusted.

The brief summary states that intention-to-treat and per-protocol analyses will be performed. In general, intention-to-treat analysis retains participants in their randomized groups, while per-protocol analysis focuses on participants meeting specified adherence or eligibility criteria. The registry record does not define the per-protocol population, report how participants were handled in either analysis, or provide results for either approach.

The summary also mentions sensitivity analysis to assess the impact of missing data on the treatment effect if necessary. It does not state how missing observations would be handled, what assumptions would be used, or what sensitivity procedures would be applied. Those details, as well as the amount and pattern of missing outcome data, are not reported in the registry record. Without these details and the corresponding results, robustness to missing data cannot be evaluated.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record lists the app-based acupressure group and the control group with 30 participants at risk for serious adverse events in each group, and records zero serious adverse events in both. It also lists 30 participants at risk for other adverse events in each group, with zero recorded in both groups. Deaths are recorded as zero in each group. No serious adverse event terms are listed.

These are the safety counts recorded in the registry, not a detailed account of how adverse events were collected, classified, or followed. Zero recorded events means that the record reports none for these categories; it does not establish that no events occurred outside the reporting process or that an intervention is free of risk. The registry record does not provide event definitions, surveillance procedures, event timing, or a narrative of potential events. The counts should therefore be read narrowly as the posted safety information, not as a complete safety assessment.

12. What the Result Does, and Does Not, Mean

The record documents a trial designed to compare an app-based acupressure program with usual care for hemodialysis patients. It specifies a primary fatigue scale and assessment schedule, and it names pruritus and sleep quality as secondary outcomes. Those details establish what investigators intended to evaluate; they do not establish what the outcome data showed.

The registry record lists zero analyses and does not report outcome estimates or uncertainty measures. There is therefore no posted evidence from which to describe the size, direction, or precision of a difference between groups. In particular, no conclusion about improvement, worsening, or equivalence in fatigue, pruritus, or sleep quality can be drawn from the design description alone. A missing result is not a null result.

The record also does not report whether any observed difference, if later reported, would be important to patients or clinically meaningful. Statistical evidence and clinical importance are distinct: statistical estimates describe patterns and uncertainty in data, while judgments about practical importance require appropriate contextual evidence. No such outcome estimates or threshold for meaningful change are given in the registry record.

The listed adverse-event counts are reassuring only in the limited sense that the registry records zero events in the stated categories for the listed groups. They do not resolve broader questions about harms because event definitions, monitoring, and detailed reporting are not included. Overall, the registry record supports an account of the trial’s structure and planned measurement, but its posted results are insufficient for conclusions about benefit, lack of benefit, or safety.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is broader than a simple end-of-treatment comparison. Fatigue is measured repeatedly from baseline through follow-up, so a suitable analysis needs to account for both changes over time and the relationship among observations from the same participant. The registry’s description of generalized estimating equations signals that repeated-measures structure was part of the planned analysis.

The record also illustrates why outcome definitions and score direction matter. The fatigue scale is reversed for analysis, while higher total scores are described as more severe fatigue. Clear interpretation of any eventual estimate depends on retaining that stated direction and identifying which group contrast and assessment occasion the estimate represents.

There are also several outcomes: fatigue is primary, while pruritus and sleep quality are secondary. When studies examine multiple outcomes and time points, transparent reporting of the planned contrasts and any approach to multiplicity helps readers distinguish primary evidence from additional analyses. Those details and the resulting estimates are not reported in the registry record.

Finally, the record separates a described analytical plan from available evidence. It names GEE, intention-to-treat and per-protocol approaches, and a possible missing-data sensitivity analysis, but lists no analyses. This distinction is important: a statistical method can clarify how results might be estimated, but it cannot provide findings when estimates and uncertainty are absent. The record is informative about the question and measurement plan, while leaving the empirical comparison unresolved.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this trial record is the absence of posted outcome analyses. No group summaries, model estimates, confidence intervals, or p-values are reported for fatigue, pruritus, or sleep quality. Consequently, the magnitude and precision of any group differences cannot be assessed. Although the status is listed as completed, completion status alone does not supply the missing outcome results.

The description of masking does not identify who was masked. The record also does not report the randomization sequence procedure, allocation concealment, the detailed GEE specification, covariates, or the contrast used for the primary question. The brief summary mentions intention-to-treat and per-protocol analyses but does not define the analysis populations or provide results for them.

Missing-data handling is not specified beyond a possible sensitivity analysis if necessary. The amount and pattern of missingness, any imputation or other procedure, and sensitivity-analysis findings are not reported in the registry record. Multiplicity handling across outcomes and time points is also not reported. These omissions prevent assessment of the robustness and scope of any inferential claims.

The record lists enrollment as 60, while the summary describes an estimated recruitment range of 50 to 100 participants. It does not explain the basis for the enrollment target or give a prospective sample-size justification. The planned single-hospital setting is described in the summary, which may limit how broadly the study population and care context can be represented; details of the hospital and participant characteristics are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients — NCT07259369.
• Registry record last updated 2026-10-29; status last verified 2026-10.
• Results first posted 2026-10-28.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes a completed, randomized, single-masked, parallel trial of app-based self-guided acupressure compared with usual care among hemodialysis patients. It lists an enrollment of 60 and describes 1:1 allocation. The intervention is performed once daily for 4 weeks.

Fatigue is the primary outcome, measured using the Post-dialysis Fatigue scale at baseline, 2 weeks during intervention, immediately after intervention, 4 weeks after intervention, and 8 weeks after intervention. Pruritus and sleep quality are secondary outcomes. The summary describes GEE, intention-to-treat and per-protocol analyses, and possible sensitivity analysis for missing data.

The record lists zero analyses and does not report outcome estimates. It records zero serious adverse events, zero other adverse events, and zero deaths in each group. Results about comparative outcomes and broader safety interpretation are therefore not available in the registry record.