Sexual Satisfaction
Conditions
Brief summary
The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants. As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.
Detailed description
Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.
Interventions
DEVICENon-Invasive Neuromodulation (NESA)
Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects from 18 to 65 years * Sexually active * Signed consent form
Exclusion criteria
* Diagnosed diseases. * Severe previous psychiatric conditions. * Medical contraindications that prevent the use of non-invasive neuromodulation therapy. * Having exercised in the hours prior to the NESA treatment. * Having consumed coffee or tobacco in the hours prior to the treatment. * Minors. * Individuals who have previously received any type of neuromodulation treatment. * Cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual satisfaction | 10 minutes | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress levels | 10 minutes | Questionnaire |
| Blood Pressure (Sistolic and diastolic) | 5 minutes | Sfignomanometer |
| Heartbeats per minute | 5 minutes | We Cardio http://en.wecardio.com/3\_1ourmachinepage.html |
| Sleep Quality | 10 minutes | Questionnaire |
Countries
Spain
Outcome results
None listed