Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer

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: NCT03003611
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:

The investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose).

Patient will be informed that some parameters, about his recovery, will be collected from their medical file. They will not have another particular treatment because they are in the study. It is just a prospective data collection.

The patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) Also the investigators will compare the impact of hypnose on the other treatments the patient received.

The investigators need approximately 150 patients (Half in each arm).


Condition or disease Intervention/treatment
Early Stage Breast Carcinoma Procedure: hypnose sedation Procedure: general anesthesia

Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hypnose
the group of patient who's operated under hypnose sedation
Procedure: hypnose sedation
Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia

traditional anesthesia
The match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery.
Procedure: general anesthesia
Patient will be anesthetized with a classical general anesthesia




Primary Outcome Measures :
  1. How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales. [ Time Frame: One day after the surgery ]

    We'll collect the following information in the standard medical file :

    The collected measures who will analyzed are anxiety, pain and consumption of analgesic.

    Items :

    1. Anxiety (will be mesured by the anxiety visual scale)
    2. Pain (mesured by analogic visual pain scale)
    3. consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).


Secondary Outcome Measures :
  1. How is the recovering of the patient according his pain and anxiety, seven days after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales. [ Time Frame: 7 days after surgery ]

    We'll collect the following information in the standard medical file :

    The collected measures who will analyzed are anxiety, pain and consumption of analgesic.

    Items :

    1. Anxiety (will be mesured by the anxiety visual scale)
    2. Pain (mesured by analogic visual pain scale)
    3. consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).

  2. Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)? [ Time Frame: 7 days post surgery ]

    We'll collect the following information in the standard medical file :

    • Redness of the skin : yes /no
    • Delay in the scar process : yes/ no
    • Infection: yes/ no
    • Hypertrophie of the scar : yes/no
    • Pain : Yes/No After analysis of the parameters, we will determine a good scar healing process, or not.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient who will benefit of a surgery according a early stage of in-situ or infiltrated breast cancer
Criteria

Inclusion Criteria:

  • Signed informed consent Form
  • In situ breast cancer (early stage)
  • Infiltrated Breast cancer (early stage)

Exclusion Criteria:

  • No hypnoses is possible for this patient surgery

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): NCT03003611


Locations
Layout table for location information
Belgium
Cliniques universitaires Saint-Luc - UCL
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Study Director: Martine Berlière, MD PhD Cliniques universitaires Saint-Luc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03003611     History of Changes
Other Study ID Numbers: ONCO-GYNECO 2014/1
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs