Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery (OncoHypnose)
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
General anesthesia
Hypnosis sedation
General anesthesia with preoperative session of hypnosis
Sponsored by

About this trial
This is an interventional treatment trial for Breast Neoplasm
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
Sites / Locations
- Hôpital de Jolimont
- Cliniques Universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
General anesthesia
Hypnosis sedation
General anesthesia with preoperative session of hypnosis
Arm Description
Patients will undergo oncologic breast surgery on general anesthesia.
Patients will undergo oncologic breast surgery on hypnosis sedation.
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
Outcomes
Primary Outcome Measures
Number of the days spent at the hospital post-surgery between the three groups
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)
Blood test performed
Secondary Outcome Measures
Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation
Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system
Full Information
NCT ID
NCT03330717
First Posted
October 19, 2017
Last Updated
June 21, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03330717
Brief Title
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
Acronym
OncoHypnose
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia
Arm Type
Placebo Comparator
Arm Description
Patients will undergo oncologic breast surgery on general anesthesia.
Arm Title
Hypnosis sedation
Arm Type
Experimental
Arm Description
Patients will undergo oncologic breast surgery on hypnosis sedation.
Arm Title
General anesthesia with preoperative session of hypnosis
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
Patients will undergo oncologic breast surgery on general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Hypnosis sedation
Intervention Description
Patients will undergo oncologic breast surgery on hypnosis sedation.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia with preoperative session of hypnosis
Intervention Description
Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.
Primary Outcome Measure Information:
Title
Number of the days spent at the hospital post-surgery between the three groups
Description
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
Time Frame
Day 0, 1, 8 and every 3 months for 2 years after surgery
Title
Comparaison of inflammatory parameters measured on day 0,1,8: CRP ( c reactive protein) and NLR ( neutrophils to lymphocyte ratio)
Description
Blood test performed
Time Frame
Day 0, 1, 8
Secondary Outcome Measure Information:
Title
Substudy evaluation of salivary immunoglobulins and endocannabinoids among 50 patients (25 under general anesthesia and 25 under hypnosis sedation
Description
Blood and salivary simples to observe if hypnosis modifies salivary parameters and endocannabinoids system
Time Frame
Simples collected on Day 0, 1 and 8 for endocannabinoids and salivary simples collected on Day 0 and 8
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women with breast cancer will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Berlière, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de Jolimont
City
Haine-Saint-Paul
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
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