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

Study Overview
=================
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.

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

Conditions
-----------------
Surgery, Oncology

Intervention / Treatment
-----------------
* Other: cardiac coherence program coupled with hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Patient with a scheduled surgery for a cancer (suspected or declared) with a classic or ambulatory hospitalization Patients requiring general anesthesia with or without associated loco-regional anesthesia or loco-regional anesthesia alone Patient with a smartphone or a tablet or a computer and able to install the application Inclusion of the patient minimum 7 days before the date of the surgery Patient who signed the informed consent Patient affiliated to a French social security system Exclusion Criteria: Emergency surgery Plastic surgery for reconstruction: lipomodelling Prophylactic surgery: no suspected or existing cancer Bradycardia (< 50 beats/minute) with β-blockers Severe heart failure with ventricular ejection fraction < 40% Uncontrolled chronic pain for more than three months on morphine Patient with unstable epilepsy or respiratory pathology with rest dyspnea Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation, music therapy, virtual reality, ... 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) Deaf patient without hearing aids Patient under guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis. | Other: cardiac coherence program coupled with hypnosis<br>* 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).<br>|
| No Intervention: Control group<br>Classic management of the preoperative period | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The morning of the surgery (Day 0) upon arrival in the operating room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | Between -15 to -7 days before surgery (Day -15 to Day -7) | 
| Measurement of global anxiety level by using a Visual Analogue Scale (VAS) | 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). | 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 | Between -15 to -7 days before surgery | 
| VAS values and individual psycho-clinical characteristics | 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) (defined as VAS at Day 0 ≥ 40), and individual psycho-clinical characteristics (gender, smoking, psychological questionnaires). | Between -15 to -7 days before surgery and the day of surgery (Day 0) | 
| Number of patients taking benzodiazepine | Rate of patients taking benzodiazepines in the 2 groups | The day after surgery (Day 1) | 
| Number of days of hospitalization | Length of hospital stay in the 2 groups | The day after surgery (Day -1) and up to 1 month | 
| VAS values and mode of hospitalization and importance of the surgical procedure | 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, and the mode of hospitalization (ambulatory or conventional) and the importance of the surgical procedure (minor, intermediate or major) | The morning of the surgery (Day 0) upon arrival in the operating room | 
| Doses of hypnotic and morphine drugs | Doses of hypnotic and morphine drugs administered during anesthetic induction (Day 0) in the 2 groups | During anesthetic induction (Day 0) | 
| Value of preoperative VAS and adverse events | 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 and adverse event variables: pain, agitation, postoperative nausea and vomiting (PONV), ... | The morning of the surgery (Day 0) upon arrival in the operating room | 
| Number of Self-questionnaire completed | Self-questionnaire completion rates for each of the 2 pre- and postoperative periods | From the day of the anesthesia consultation until the end of the study | 
| Evaluation of the Vecu of General Anesthesia questionnaire (EVAN-G) | The EVAN-G questionnaire includes 26 questions whose results are grouped together to define 6 dimensions: Attention Focus, Information, Privacy, Pain, Discomfort and Wait Times. From these scores, an overall satisfaction score is calculated. The total score of the six dimensions reduced to 100. | Two day after surgery (Day 2) | 
| Visual Analogue Scale (VAS) of pain | Visual Analogue Scale (VAS) of pain is a pain self-assessment scale that allows the patient to self-assess his or her pain using a cursor | At 1, 2 and 3 month after surgery | 
| Quality of Recovery (QoR) | The QoR-15 questionnaire assesses five dimensions of recovery : physical comfort; emotional state; physical independence; physiological support; and pain. Each item was rated on a ten-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score of 15 ranges from 0 (poorest quality of recovery) to 150 (best quality of recovery). | The day after surgery (Day 1) | 
| Insomnia Severity Index Scale (ISI) | The Insomnia Severity Index (ISI) includes 7 questions which assesses the nature of the insomnia, the person's satisfaction with sleep, daily functioning and anxiety about sleep problems. Add scores for all seven items, sum from 0-7 = No clinically significant insomnia to 22-28 = Clinical insomnia (severe). | The day after surgery (Day 1) | 
| VAS of on satisfaction with overall management and anesthesia | Visual Analogue Scale (VAS) of on satisfaction with overall management and anesthesia is a satisfaction self-assessment scale that allows the patient to self-assess his or her satisfaction using a cursor. The scale ranges from 0 (not at all satisfied) to 100 (completely satisfied) | The day after surgery (Day 1) |