Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery

Recruiting now

Conditions studied: Anxiety

In brief

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 low. Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety. We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).

Key facts

Study ID

NCT07070986

Run by

Hospices Civils de Lyon

People needed

62

Starts

2025-09-30

Expected to finish

2027-03-03

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned cardiac surgery with extracorporeal circulation
• Pre operatory anxiety : STAI-E score >30 or Visual Analogue Scale Anxiety >6

You may not qualify if…

• 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 is running

• Hopitallouis Pradel — Bron, France (enrolling)

Full record on ClinicalTrials.gov

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