Study Procedures
pain
PAINFUL PERIODS
Upon inclusion, eligible patients were randomized to either the Endocare or control arm, were given the study devices and a follow-up diary, and instructed on how to use these materials during their 5 days of participation. Patients were asked to use the treatment starting on their first day of painful periods (next cycle after study inclusion) and up to twice a day with a minimum of 3 hours between exposures. Patients were given the possibility to stop their study treatment after 2 days in case of pain relief and to continue using their usual medications while reporting their uses in their follow-up diary (drug name, dose, frequency).For the baseline assessment, once enrolled, patients were invited to complete 2 questionnaires to assess their baseline profiles: EHP-5 questionnaire and PCS. The 11 items from the EHP-5 questionnaire were rated from “never” to “always,” while dramatization (PCS) was evaluated on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (all the time).Subsequently, on their first day of pain, patients informed the investigating staff of their treatment initiation (day 1) and started completing their daily follow-up diary for 5 days.