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Recruiting 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

— Observational Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RESC, NSCS.
Who it may be relevant to
Registry conditions: Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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).

Interventions

  • Procedure RESC
    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.
  • Other NSCS
    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 outcome measures

  • LF/HF ratio variation compared between the groups [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
Secondary outcome measures (9)
  • Skin conductance variation compared between the groups [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Perfusion index variations compared between the groups. [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Analgesia nociception index compared between the groups [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Anxiety compared between the groups [Time frame: After de RESC/NCS session]
  • Morphine use post-surgery compared between the groups [Time frame: Day 1]
  • Anxiety compared between the groups [Time frame: After de RESC/NCS session]
  • Heart rate variations compared between the groups. [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Blood pressure variations compared between the groups. [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Respiratory rate variations compared between the groups. [Time frame: Between the beginning and the end of the RESC/NCS session (20 minutes)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hopitallouis Pradel — Bron

Identifiers

NCT: NCT07070986 · 69HCL24_1239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗