Early Stage Breast Carcinoma
Conditions
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).
Interventions
PROCEDUREhypnose sedation
Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
PROCEDUREgeneral anesthesia
Patient will be anesthetized with a classical general anesthesia
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 : 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
| Measure | Time frame | Description |
|---|---|---|
| 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 : 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). |
| 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. |
Countries
Belgium
Outcome results
None listed