Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulati
Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required. The autonomic nervous sy
| Condition(s) | Anxiety |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required. The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate. Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if |
| Who can participate | Inclusion Criteria: * Planned cardiac surgery with extracorporeal circulation * Pre operatory anxiety : STAI-E score \>30 or Visual Analogue Scale Anxiety \>6 Exclusion Criteria: * Urgent surgery * Atrial fibrillation * Impossibility to answer to STAI-E or VAS * Use of alternative method * Use of an alternative method other for anxiety before inclusion * Absence of consent * Pregnant, breastfeeding women. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Bron, France |
| Start date | 2025-09-30 |
| NCT ID | NCT07070986 |
| Official listing | https://clinicaltrials.gov/study/NCT07070986 |