Cutaneous resonance stimulation to reduce preoperative anxiety in cardiac surgery patients
Official title: Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation on SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
Run by Hospices Civils de Lyon · NCT07070986 · Data updated 2026-11-12
This pilot will test whether gentle skin stimulation called cutaneous resonance stimulation can shift autonomic balance and lower anxiety in adults scheduled for elective cardiac surgery with extracorporeal circulation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | March 3, 2027 |
| Study ends | March 3, 2027 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07070986 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for elective cardiac surgery requiring extracorporeal circulation who have elevated preoperative anxiety (STAI-E > 30 or VAS anxiety > 6), can consent and complete questionnaires, and are not pregnant or breastfeeding.
✕Probably not a fit
Patients undergoing urgent surgery, those in atrial fibrillation, those unable to complete anxiety questionnaires, those already using other alternative anxiety methods, and pregnant or breastfeeding women are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-blind, randomized pilot compares cutaneous resonance stimulation (RESC) with a control skin stimulation (NSCS) in patients awaiting planned cardiac surgery with extracorporeal circulation. Anxiety will be measured by self-report scales (STAI-E, VAS) and by heart rate variability metrics derived from RR intervals, including HF, LF, and the LF/HF ratio as markers of parasympathetic and sympathetic tone. Patients with preoperative anxiety above prespecified thresholds are randomized before surgery and studied perioperatively. The protocol excludes urgent cases, atrial fibrillation, inability to complete questionnaires, prior use of alternative anxiety methods, and pregnancy or breastfeeding.
Why it matters
Potential benefit: If successful, this could provide a simple, non-drug way to reduce preoperative anxiety and potentially lower postoperative pain and complications.
How similar studies have gone: Other nonpharmacologic interventions like relaxation, massage, and hypnosis have reduced preoperative anxiety and altered HRV in prior work, but cutaneous resonance stimulation is a novel technique with limited direct prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hopitallouis Pradel
Bron, France Recruiting
Study contacts
- Study coordinator: CHARRION Chantal
- Email: chantal.clement-charrion01@chu-lyon.fr
- Phone: 00337 86 50 03 82
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.