ABSTRACT: BACKGROUND: The aim of this double-blind randomized study was to test the efficacy of a radio electric stimulator device using an auricular reflex therapy protocol for stress-related psichological and physical symptoms. METHODS: The study was carried out on 200 subjects (138 females and 62 males) that voluntarily came to our Institute declaring to \"feel stressed.\" The participants were randomly allocated with a computerized procedure; 150 were treated with an auricular therapeutic protocol with a radio electric stimulator device (REAC) and 50 were treated with an inactivated, placebo REAC. Psychological stress was evaluated trough a self-administered questionnaire (Psychological Stress Measure [PSM]). Assessment data were collected at 2 time points (before the treatment [T0] and immediately after the therapy cycle of 18 sessions, approximately 4 weeks later [T1]). RESULTS: In the group treated with REAC, the psychometric evaluation after the therapy cycle showed a significant reduction in the PSM total scores (107.8 +/- 23.13 at T0 to 87.1+/- 16.21 at T1;p<0.5), while in the control group no significant variation in decreasing stress-related symptomatology was noted (107.86 +/- 25.80 at T0 and 106.32 +/- 25.88 at T1; p=NS). CONCLUSIONS: The protocol of the auricular treatment with REAC appears to reduce the subjective perception of stress as \"psychometrically\" demonstrated by the significant reduction in the PSM test total score. This therapeutic procedure also provides a non-invasive, painless, and very simple innovative approach to treat the wide range of stress-related disorders. Trial Registration This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number: ACTRN12607000529448.

Psychometric evaluation of a radio electric auricular treatment for stress related disorders:a double-blinded, placebo-controlled controlled pilot study.