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

Not yet recruiting

• Conditions: Anxiety

• Registration Number: NCT07070986
• Lead Sponsor: Hospices Civils de Lyon

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LF/HF ratio variation compared between the groups	Between the beginning and the end of the RESC/NCS session (20 minutes)	LF and HF will be monitored during the all RESC/NSCS.

Secondary Outcome Measures

Name	Time	Method
Skin conductance variation compared between the groups	Between the beginning and the end of the RESC/NCS session (20 minutes)	Skin conductance will be monitored during the all RESC/NSC session.
Perfusion index variations compared between the groups.	Between the beginning and the end of the RESC/NCS session (20 minutes)	Perfusion index ration will be monitored during the all RESC/NSC session.
Morphine use post-surgery compared between the groups	Day 1	Cumulative morphine used
Heart rate variations compared between the groups.	Between the beginning and the end of the RESC/NCS session (20 minutes)	Heart rate variation will be monitored during the all RESC/NSC session.
Blood pressure variations compared between the groups.	Between the beginning and the end of the RESC/NCS session (20 minutes)	Blood pressure be monitored during the all RESC/NSC session.
Respiratory rate variations compared between the groups.	Between the beginning and the end of the RESC/NCS session (20 minutes)	Respiratory rate will be monitored during the all RESC/NSC session.
Analgesia nociception index compared between the groups	Between the beginning and the end of the RESC/NCS session (20 minutes)	Analgesia nociception index will be monitored during the all RESC/NSC session.
Anxiety compared between the groups	After de RESC/NCS session	Anxiety will be assessed by STAI-E

Trial Locations

Locations (1)

Hopitallouis Pradel; 🇫🇷 Bron, France