Statistics
In IA, the feasibility was documented by describing the process from the log registration and response using a VAS with a cut-off value of 5. The time spent on the test was compared between the groups by a Mann-Whitney test; In IB, using Kappa statistics, the validity was analyzed for inter-variability among patients and staff. A substantial agreement was considered acceptable, i.e., a result of Kappa > 0.60. However, 0.81–1.00 would be considered an almost perfect agreement.The pilot results were expected to be used for the following power calculation regarding a possible final randomized trial on efficacy (part II).