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

Not Applicable

Completed

• Conditions: Breast Neoplasm
• Interventions: Procedure: General anesthesia with preoperative session of hypnosis; Procedure: General anesthesia; Procedure: Hypnosis sedation

• Registration Number: NCT03330717
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2017-11-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia with preoperative session of hypnosis	General anesthesia with preoperative session of hypnosis	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
General anesthesia	General anesthesia	Patients will undergo oncologic breast surgery on general anesthesia.
Hypnosis sedation	Hypnosis sedation	Patients will undergo oncologic breast surgery on hypnosis sedation.

Primary Outcome Measures

Name	Time	Method
Number of the days spent at the hospital post-surgery between the three groups	Day 0, 1, 8 and every 3 months for 2 years after surgery	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
Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)	Day 0, 1, 8	Blood test performed

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hôpital de Jolimont; 🇧🇪 Haine-Saint-Paul, Hainaut, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium