Clinical trial NCT03330717: Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
Official title: Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of the days spent at the hospital post-surgery between the three groups
timeFrame: Day 0, 1, 8 and every 3 months for 2 years after surgery
measure: Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)
timeFrame: Day 0, 1, 8
Secondary outcomes:
measure: Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation
timeFrame: Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8
Other outcomes:
Locations:
city: Haine-Saint-Paul
country: Belgium
facility: Hôpital de Jolimont
state: Hainaut
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Martine Berlière, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: