Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery

Last updated: April 11, 2025
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Neoplasms

Cancer

Treatment

cardiac coherence program coupled with hypnosis

Clinical Study ID

NCT05197972
PROICM 2021-09 COH
2021-A01524-37
  • Ages > 18
  • All Genders

Study Summary

The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old

  2. Patient with a scheduled surgery for a cancer (suspected or declared) with a classicor ambulatory hospitalization

  3. Patients requiring general anesthesia with or without associated loco-regionalanesthesia or loco-regional anesthesia alone

  4. Patient with a smartphone or a tablet or a computer and able to install theapplication

  5. Inclusion of the patient minimum 7 days before the date of the surgery

  6. Patient who signed the informed consent

  7. Patient affiliated to a French social security system

Exclusion

Exclusion Criteria:

  1. Emergency surgery

  2. Plastic surgery for reconstruction: lipomodelling

  3. Prophylactic surgery: no suspected or existing cancer

  4. Bradycardia (< 50 beats/minute) with β-blockers

  5. Severe heart failure with ventricular ejection fraction < 40%

  6. Uncontrolled chronic pain for more than three months on morphine

  7. Patient with unstable epilepsy or respiratory pathology with rest dyspnea

  8. Patient used to and having a regular and habitual practice of relaxation techniquessuch as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ...

  9. Medical (neurological, psychiatric, etc.) or psychological conditions not allow forparticipation in the protocol (completion of questionnaires and booklet, compliancewith the cardiac coherence program coupled with hypnosis)

  10. Deaf patient without hearing aids

  11. Patient under guardianship or curatorship

Study Design

Total Participants: 296
Treatment Group(s): 1
Primary Treatment: cardiac coherence program coupled with hypnosis
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2026

Study Description

The perioperative period is recognized as anxiety-provoking for most patients. In oncology, 60 to 80% of patients suffer from stress throughout their treatment. If for some patients, this anxiety is more or less manageable, for others, it is the major concern with regard to their intervention.

For many years, pharmacological premedication, especially with benzodiazepines, has been the gold standard for the treatment of preoperative anxiety, but this systematic prescription is increasingly controversial, especially in populations most exposed to side effects, such as elderly subjects and patients with cardiac or respiratory pathologies.

The aim of this study is to propose an alternative to pharmacological premedication by a non-drug approach.

The two techniques (the Fixed Rate Guided Breathing Technique = cardiac coherence and hypnosis) can potentiate each other and become synergistic. Thus, for patients undergoing oncological surgery, regular practice of cardiac coherence coupled with hypnosis prior to their surgery should enable them to better manage perioperative anxiety and thus significantly reduce their level of anxiety on the day of their surgery.

The association of the 2 techniques combines several advantages:

  • It is totally "physiological", free and immediately available for the patient and without any undesirable effect;

  • It gives autonomy to the patient to manage his stress, making him independent of chemical molecules, the presence of a third party or expensive equipment.

  • It will allow oncology patients to use it throughout their care (invasive examinations, MRI imaging, heavy and complex care such as certain dressings, etc.)

This work will allow:

  • To give oncology patients the possibility to be actors of their care by a self-management of their anxiety in substitution or complement of a medicated approach;

  • To map anxiety in oncology surgery using a simple scale such as the EVA, which has not yet been done;

  • To identify the most anxious patients in order to provide them with the appropriate management (pharmacological and/or NMI) before their surgery;

  • To evaluate the correlation between the level of preoperative anxiety and the occurrence of postoperative adverse events;

  • To evaluate the correlation between the level of anxiety and the quality of recovery (QoR) and the postoperative experience (EVAN-G).

Patients in the experimental group will be interviewed to explain how to perform the cardiac coherence and hypnosis sessions at home before the surgery.

Connect with a study center

  • Institut régional du cancer de Montpellier

    Montpellier, Hérault 34298
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

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