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

NCT07070986 | Recruiting

• 1 other identifier: 69HCL24_1239
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Keywords

Anxiety; Cardiac surgery; Pain; RESC

Outcome Measures

Primary Outcomes (1)

• LF/HF ratio variation compared between the groups

  LF and HF will be monitored during the all RESC/NSCS.

  Between the beginning and the end of the RESC/NCS session (20 minutes)

Secondary Outcomes (9)

• Skin conductance variation compared between the groups

  Between the beginning and the end of the RESC/NCS session (20 minutes)

• Perfusion index variations compared between the groups.

  Between the beginning and the end of the RESC/NCS session (20 minutes)

• Analgesia nociception index compared between the groups

  Between the beginning and the end of the RESC/NCS session (20 minutes)

• Anxiety compared between the groups

  After de RESC/NCS session

• Morphine use post-surgery compared between the groups

  Day 1

Study Arms (2)

CUTANEOUS RESONANCE STIMULATION (RESC)

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.

Procedure: RESC

NON SPECIFIC CUTANEOUS STIMULATION (NSCS)

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.

Other: NSCS

Interventions

RESC PROCEDURE

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.

CUTANEOUS RESONANCE STIMULATION (RESC)

NSCS OTHER

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.

NON SPECIFIC CUTANEOUS STIMULATION (NSCS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for cardiac surgery with significant preoperative anxiety.

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
• Absence of consent
• Pregnant, breastfeeding women.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopitallouis Pradel

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHARRION Chantal

CONTACT

00337 86 50 03 82; chantal.clement-charrion01@chu-lyon.fr

CANTERINI JULIA

CONTACT

00334 27 85 66 28; Julia.canterini@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 17, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)