Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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. [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 : Anxiety (will be mesured by the anxiety visual scale) Pain (mesured by analogic visual pain scale) 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
- 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. [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 : Anxiety (will be mesured by the anxiety visual scale) Pain (mesured by analogic visual pain scale) 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).
- 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)? [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques universitaires Saint-Luc - UCL | Brussels | Belgium | 1200 |
Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
- Study Director: Martine Berlière, MD PhD, Cliniques universitaires Saint-Luc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ONCO-GYNECO 2014/1