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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Anxiety

Treatments: Procedure: RESC; Other: NSCS

Study type: Observational

Funder types: Other

Identifiers

NCT07070986

69HCL24_1239

Details and patient eligibility

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).

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

62 participants in 2 patient groups

CUTANEOUS RESONANCE STIMULATION (RESC)

Description:

If randomized in the RESC group, interventional group, patient will receive a 20 minutes session of cutaneous resonance stimulation before his cardiac surgery according to a standardized protocol.

Treatment:

Procedure: RESC

NON SPECIFIC CUTANEOUS STIMULATION (NSCS)

Description:

If randomized in the NSCS group, control group, patient will receive a 20 minutes session of non-specific cutaneous stimulation before his cardiac surgery according to a standardized protocol.

Treatment:

Other: NSCS