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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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General anesthesia

Patients will undergo oncologic breast surgery on general anesthesia.

Group Type PLACEBO_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

Patients will undergo oncologic breast surgery on general anesthesia.

Hypnosis sedation

Patients will undergo oncologic breast surgery on hypnosis sedation.

Group Type EXPERIMENTAL

Hypnosis sedation

Intervention Type PROCEDURE

Patients will undergo oncologic breast surgery on hypnosis sedation.

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

Group Type EXPERIMENTAL

General anesthesia with preoperative session of hypnosis

Intervention Type PROCEDURE

Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.

Interventions

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General anesthesia

Patients will undergo oncologic breast surgery on general anesthesia.

Intervention Type PROCEDURE

Hypnosis sedation

Patients will undergo oncologic breast surgery on hypnosis sedation.

Intervention Type PROCEDURE

General anesthesia with preoperative session of hypnosis

Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No