Effects of four non-invasive Neuromodulation methods on Sexual Diseases : randomized clinical trial

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2024
INTERVENTION: This is a multi‐arm, double‐blind, randomized clinical trial with a quantitative approach and proportional allocation of subjects (1:1). All groups will receive treatment for five days, with experimental group 1: 10 women with genito‐pelvic pain/penetration will receive transcranial direct current stimulation for 20 minutes, with an intensity of 3mA and manual perineal massage for five minutes. Experimental group 2: 10 women with genito‐pelvic/penetration pain will receive transcranial alternating current stimulation for five minutes with a pulse frequency of 5Hz and manual perineal massage for five minutes. Experimental group 3: 10 women with genito‐pelvic pain/penetration will receive electrostimulation of the vagus nerve for 20 minutes with a pulse width of 0.25ms, pulse frequency of 25hz and manual perineal massage for five minutes. Experimental group 4: 10 women with genital‐pelvic/penetration pain will receive mindfulness for 15 minutes and perineal manual massage for five minutes. Control group: 10 women with genital‐pelvic pain/penetration will receive perineal manual massage for five minutes and sham electrical stimulation with transcranial electrodes, however, there will be no current transmission, giving the placebo so that there is blinding in this group. Randomization will occur by concealing the allocation of participants into the intervention and control groups, by applying a series of codes randomly generated by the free software CLINAST, and the numerical sequence will be kept inside brown envelopes and must be distributed by a researcher who is unaware the codes generated for each group. In order for there to be masking, both the participants, the team responsible for applying the intervention, and the outcome evaluators will not know what each partici CONDITION: C12.100.875 Dyspareunia; Pelvic pain PRIMARY OUTCOME: It is expected to find a significant improvement in the pain sensation in the participants of the G1 group, when compared to the G2, G3, G4 and GC. And that this improvement in pain has a positive impact on the sexual function of these women. In addition, to bring reflections to the scientific community on new means of treatment for the area of ??women's/pelvic health, which promote confidence, comfort and shorter treatment time for patients with Dor Gênito Pélvica Penetração. SECONDARY OUTCOME: No secondary outcomes are expected. INCLUSION CRITERIA: women aged between 20 and 45 years; who report a persistent or recurrent complaint for at least si Xmonths of at least one of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Appendi XC), 5th edition of the American Psychiatric Association (2014), namely: 1) significant pain during intercourse or penetration attempts; 2) significant fear or anxiety about pain in anticipation of, during, or because of vaginal penetration; 3) stiffness or significant tightening of the pelvic floor muscles during attempts to penetrate the vagina, which represents significant suffering due to the presence of one of these criteria
Epistemonikos ID: 8ee770e5beaa2b7e18ff608529394eacdc6e674b
First added on: Aug 28, 2024