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

Breast Neoplasm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03330717
Study type Interventional
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact
Status Completed
Phase N/A
Start date November 15, 2017
Completion date December 31, 2019
View Details
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