Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery. Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up. Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.

Detailed Description
-----------------
Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic surgery. Different side effects were measured during the post operative period and at each follow up visit by physicians in order to carefully compare side effects in the 3 armes of patients.. Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction. A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins and dosage of differents endocannabinoids

Official Title
-----------------
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Procedure: General anesthesia
* Procedure: Hypnosis sedation
* Procedure: General anesthesia with preoperative session of hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Signed informed consent form Patient has to be in possession of her administrative laws and affiliated to the social security insurance. The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection) Exclusion Criteria: Patient under 18 years old No signed informed consent form Patients who haven't her social security insurance and prisoners are not eligible. No evaluation of the axillary area. Breast cancer in men

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: General anesthesia<br>Patients will undergo oncologic breast surgery on general anesthesia. | Procedure: General anesthesia<br>* Patients will undergo oncologic breast surgery on general anesthesia.<br>|
| Experimental: Hypnosis sedation<br>Patients will undergo oncologic breast surgery on hypnosis sedation. | Procedure: Hypnosis sedation<br>* Patients will undergo oncologic breast surgery on hypnosis sedation.<br>|
| Experimental: General anesthesia with preoperative session of hypnosis<br>Patients interested in hypnosis but too anxious to have surgery while on hypnosis sedation will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation using technology of virtual reality | Procedure: General anesthesia with preoperative session of hypnosis<br>* Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the days spent at the hospital post-surgery between the three groups | The aim of the study is to compare the recovering period hospitalisation and the different side effects (pain, anxiety, fatigue and consumption of pain killers ) during the post opérative period ( day 0, 1, 8- and at each follow up visit) between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery | Day 0, 1, 8 and every 3 months for 2 years after surgery | 
| Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio) | Blood test performed | Day 0, 1, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation | Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system | Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8 |