NCT03330717

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
PROCEDURE	General anesthesia	Patients will undergo oncologic breast surgery on general anesthesia.
PROCEDURE	Hypnosis sedation	Patients will undergo oncologic breast surgery on hypnosis sedation.
PROCEDURE	General anesthesia with preoperative session of hypnosis	Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-11-06
• Last updated: 2021-06-24

Locations

2 sites across 1 country: Belgium