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NCT Number: 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

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).

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. LF/HF ratio variation compared between the groups

    Time frame: 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 outcomes

  1. Skin conductance variation compared between the groups

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

    Skin conductance will be monitored during the all RESC/NSC session.

  2. Perfusion index variations compared between the groups.

    Time frame: 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.

  3. Analgesia nociception index compared between the groups

    Time frame: 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.

  4. Anxiety compared between the groups

    Time frame: After de RESC/NCS session

    Anxiety will be assessed by visual analogue scale between 0 (no anxiety) and 10 (worst anxiety)

  5. Morphine use post-surgery compared between the groups

    Time frame: Day 1

    Cumulative morphine used

  6. Anxiety compared between the groups

    Time frame: After de RESC/NCS session

    Anxiety will be assessed by STAI-E

  7. Heart rate variations compared between the groups.

    Time frame: 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.

  8. Blood pressure variations compared between the groups.

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

    Blood pressure be monitored during the all RESC/NSC session.

  9. Respiratory rate variations compared between the groups.

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

    Respiratory rate will be monitored during the all RESC/NSC session.

Study contacts

Contact information is provided by the study sponsor or research team.

CANTERINI JULIA

CONTACT

[email protected]

00334 27 85 66 28

CHARRION Chantal

CONTACT

[email protected]

00337 86 50 03 82

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RESC SYMPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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