NCT07070986

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Anxiety

Interventions

Type	Name	Description
PROCEDURE	RESC	If randomized in the RESC group, interventional group, patient will receive a 20 minutes session of cutaneous resonance stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale (VAS) at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery). During the RESC session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored.
OTHER	NSCS	If randomized in the NSCS group, interventional group, patient will receive a 20 minutes session of non-specific cutaneous stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery) During the NSCS session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-03-03
• Completion: 2027-03-03
• First posted: 2025-07-17
• Last updated: 2025-12-19

Locations

1 site across 1 country: France