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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330717
Recruitment Status : Unknown
Verified October 2017 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The aim of the study is to compare the recovering period hospitalization length between 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Procedure: General anesthesia Procedure: Hypnosis sedation Procedure: General anesthesia with preoperative session of hypnosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
Actual Study Start Date : August 22, 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: General anesthesia
Patients will undergo oncologic breast surgery on general anesthesia.
Procedure: General anesthesia
Patients will undergo oncologic breast surgery on general anesthesia.

Experimental: Hypnosis sedation
Patients will undergo oncologic breast surgery on hypnosis sedation.
Procedure: Hypnosis sedation
Patients will undergo oncologic breast surgery on hypnosis sedation.

Experimental: 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
Procedure: General anesthesia with preoperative session of hypnosis
Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.




Primary Outcome Measures :
  1. Number of the days spent at the hospital post-surgery between the three groups [ Time Frame: an average of 1 year ]
    The aim of the study is to compare the recovering period hospitalisation length between 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women with breast cancer will be included
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330717


Contacts
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Contact: Martine Berlière, MD, PhD 0032 2 764 ext 1075 martine.berliere@uclouvain.be

Locations
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Belgium
Hôpital de Jolimont Recruiting
Haine-Saint-Paul, Hainaut, Belgium, 7100
Contact: Samartzi Vassiliki, MD    0032 26423 ext 3650    Vassiliki.SAMARTZI@jolimont.be   
Contact: Johanne Leroy, MD    0032 2 23 ext 4141    Johanne.LEROY@jolimont.be   
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Martine Berlière, MD, PhD    00 32 2 764 ext 1075    martine.berliere@uclouvain.be   
Contact: Amandine Gerday, MD    0032 2764 ext 9522    amandine.gerday@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Martine Berlière, MD, PhD Cliniques universitaires Saint-Luc
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03330717    
Other Study ID Numbers: 2016/08JUL/311
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs