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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Breast Neoplasm

Treatments: Procedure: General anesthesia with preoperative session of hypnosis; Procedure: General anesthesia; Procedure: Hypnosis sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT03330717

2016/08JUL/311

Details and patient eligibility

About

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.

Full 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

Enrollment: 284 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 3 patient groups, including a placebo group

General anesthesia

Placebo Comparator group

Description:

Patients will undergo oncologic breast surgery on general anesthesia.

Treatment:

Procedure: General anesthesia

Hypnosis sedation

Experimental group

Description:

Patients will undergo oncologic breast surgery on hypnosis sedation.

Treatment:

Procedure: Hypnosis sedation

General anesthesia with preoperative session of hypnosis

Experimental group

Description:

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

Treatment:

Procedure: General anesthesia with preoperative session of hypnosis