Data collection, data processing, data confidentiality and statistical analysis
HEART
Study data will be collected and managed using REDCap electronic data capture tools hosted at University Hospital Würzburg [During the study, the assignment of the participants to the collected data is carried out via a written assignment list, which is only accessible to the investigators. The collected data is stored in pseudonymized form. In case of a revocation, the data already collected will be deleted and, if desired, no longer processed. The data will be stored pseudonymously for a period of 10 years.The primary parameter for the evaluation of the therapeutic effects of this study is the MPA questionnaire, with the expected superiority of VRET group compared to the relaxation training group regarding the decrease of the reported symptomatology immediately after the therapy.For the primary analyses, an intention to treat (ITT) analysis will be performed for all included participants, except for those withdrawing consent during the study or not receiving at least one treatment. Missing values will be imputed using a last value carried forward approach. No interim analysis will be performed. The analysis is performed by ANCOVA with measurement repeat factor time (pre-post), the factor group (experimental-control), and the baseline values of the respective variable as covariates.Regarding HRV, we analyze the heart rate (bpm) and RMSSD as an HRV indicator. Heart rate and RMSSD each serve as a model outcome in multivariate analyzes with multiple predictors (e.g. age, gender, instrument group).