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

N/ARecruitingNCT05197972

Institut du Cancer de Montpellier - Val d'Aurelle296 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

296

Conditions

Surgery Oncology

Interventions

cardiac coherence program coupled with hypnosisOTHER

At home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application "Respirelax": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days. An audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Institut régional du cancer de Montpellier

Montpellier, Hérault, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS) of global anxiety

Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).

Time frame: The morning of the surgery (Day 0) upon arrival in the operating room

Secondary Outcomes

Program compliance

Program compliance rate of patients in the experimental group. A patient is considered compliant if he declares to have completed at least 2/3 of the proposed Cardiac Coherence sessions + listening to hypnotic tape (at least 5 days /7).

Time frame: Between -15 to -7 days before surgery (Day -15 to Day -7) until the day of surgery (Day 0)

Measurement of global and specific anxiety level by using a Visual Analogue Scale (VAS)

Visual Analogue Scale (VAS) of anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety). The patient assesses his global and specific anxiety related to: surgery, anesthesia, COVID infectious risk, fear of the unknown, oncological disease

Time frame: Between -15 to -7 days before surgery (Day -15 to Day -7)

Measurement of global anxiety level by using a Visual Analogue Scale (VAS)

Time frame: Between -15 to -7 days before surgery and the day of surgery (Day 0)

The preoperative anxiety score by using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-report questionnaire comprising six questions that have been developed and validated to evaluate the preoperative anxiety of patients. This global index assesses three separate areas: anxiety about anaesthesia, anxiety about surgery, and the desire for information. The scale scores six items from 1 to 5 (1 = absence, 5 = extreme). The APAIS scale will be used to determine the psychological profile of patients between "blunting" and "monitoring" types

Central Contacts

Jean-Pierre BLEUSE, MD

CONTACT

4 67 61 31 02 jean-pierre.bleuse@icm.unicancer.fr

Data from ClinicalTrials.gov

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