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

BACKGROUND: The aim of this double-blind randomized study is to test the efficacy of a radio electric stimulator device using an auricular reflex therapy protocol for stress-related symptoms. METHODS: The study has been carried out on 200 subjects (138 females, 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 auricular therapeutic protocol with radio electric stimulator device (REAC) and 50 were treated with an inactivated, placebo REAC. Psychological stress was evaluated trough the 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 about 4 weeks later (T1). RESULTS: In the group treated with REAC, the psychometric evaluation after the therapy's cycle showed a significant reduction of PSM total scores, from 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 has been 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 seems to reduce the subjective perception of stress, as "psychometrically" demonstrated by the significant reduction in PSM test total score. This therapeutical procedure also provides a non invasive, not painful and very simple innovative approach to treat the widely diffused stress related disorders. TRIAL REGISTRATION: This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number: ACTRN12607000529448