Computational protocol: Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial

Similar protocols

Protocol publication

[…] To estimate the sample size using G*Power® [], with assumptions (that is, α =0.05, power =0.8, three groups), estimated effect size (that is, f =0.27) and attrition rate (that is, 10%) from the pilot study [] and the previous similar studies [, ], the total number of samples needed in a randomized controlled trial to demonstrate a significant mean difference among the three groups is 99. There will therefore be 33 participants in each group. [...] Data analysis will be performed by a statistician blinded to the whole trial process using IBM SPSS Statistics 20 software []. The level of significance will be reported at P <0.05. Both per-protocol and intention-to-treat analysis will be used in order to provide more information on the effect of the intervention, considering possible confounders such as non-compliance, protocol deviations and withdrawal []. The per-protocol population is defined as participants who completed the study without major protocol violation (for example, who received more than 80% of the acupressure sessions). The intention-to-treat population is defined as participants who are randomized into groups after the collection of baseline data. Demographic and clinical data will be analyzed at baseline to measure the balance among the three groups. The results will be described by mean and standard deviation for continuous data, and by frequency and percentage for categorical data. The general estimated equation model will be used to compare the effects among groups and time points. […]

Pipeline specifications

Software tools G*Power, SPSS
Application Miscellaneous
Organisms Homo sapiens
Diseases Dementia