Actively Recruiting

Age: 18Years +
All Genders
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

Led by Hospices Civils de Lyon · Updated on 2025-12-19

62

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned cardiac surgery with extracorporeal circulation
  • Preoperative anxiety with STAI-E score greater than 30 or Visual Analogue Scale Anxiety greater than 6
Not Eligible

You will not qualify if you...

  • Urgent surgery
  • Atrial fibrillation
  • Inability to answer STAI-E or visual analogue scale
  • Use of alternative methods for anxiety before inclusion
  • Absence of consent
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopitallouis Pradel

Bron, France, 69500

Actively Recruiting

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Research Team

C

CHARRION Chantal

CONTACT

C

CANTERINI JULIA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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