Clinical trial NCT05197972: Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
Official title: Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Oncology
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group : classic management of the preoperative period Experimental group: classic management of the preoperative period with a cardiac coherence program coupled with hypnosis
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization
3. Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone
4. Patient with a smartphone or a tablet or a computer and able to install the application
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 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 techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ...
9. Medical (neurological, psychiatric, etc.) or psychological conditions not allow for participation in the protocol (completion of questionnaires and booklet, compliance with the cardiac coherence program coupled with hypnosis)
10. Deaf patient without hearing aids
11. Patient under guardianship or curatorship

Primary outcomes:
measure: Visual Analogue Scale (VAS) of global anxiety
timeFrame: The morning of the surgery (Day 0) upon arrival in the operating room
Secondary outcomes:
measure: Program compliance
timeFrame: Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)
measure: Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)
timeFrame: Between -15 to -7 days before surgery (Day -15 to Day -7)
measure: Measurement of global anxiety level by using a Visual Analogue Scale (VAS)
timeFrame: Between -15 to -7 days before surgery and the day of surgery (Day 0)
measure: The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: Between -15 to -7 days before surgery
measure: VAS values and individual psycho-clinical characteristics
timeFrame: Between -15 to -7 days before surgery and the day of surgery (Day 0)
measure: Number of patients taking benzodiazepine
timeFrame: The day after surgery (Day 1)
measure: Number of days of hospitalization
timeFrame: The day after surgery (Day -1) and up to 1 month
measure: VAS values and mode of hospitalization and importance of the surgical procedure
timeFrame: The morning of the surgery (Day 0) upon arrival in the operating room
measure: Doses of hypnotic and morphine drugs
timeFrame: During anesthetic induction (Day 0)
measure: Value of preoperative VAS and adverse events
timeFrame: The morning of the surgery (Day 0) upon arrival in the operating room
measure: Number of Self-questionnaire completed
timeFrame: From the day of the anesthesia consultation until the end of the study
measure: Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G)
timeFrame: Two day after surgery (Day 2)
measure: Visual Analogue Scale (VAS) of pain
timeFrame: At 1, 2 and 3 month after surgery
measure: Quality of Recovery (QoR)
timeFrame: The day after surgery (Day 1)
measure: Insomnia Severity Index Scale (ISI)
timeFrame: The day after surgery (Day 1)
measure: VAS of on satisfaction with overall management and anesthesia
timeFrame: The day after surgery (Day 1)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du cancer de Montpellier
state: Hérault
city: Lyon
country: France
facility: Centre Léon Bérard
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: Jibba AMRAOUI, MD
role: STUDY_CHAIR
affiliation: Institut Universitaire du Cancer Toulouse - Oncopole
name: Régis FUZIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Lauriane Bordevane, MD
role: PRINCIPAL_INVESTIGATOR
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