Breast Cancer
Conditions
Brief summary
Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Detailed description
Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects. Among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety. This study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Interventions
BEHAVIORALHypnosis
The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female \> 18 years * Patient with ASA\* score 1, 2, 3 * Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…) * Day case surgery (ambulatory surgery - living Day0-Day1) * General anesthesia required * Written informed consent * French medical benefit
Exclusion criteria
* Age \< 18 years * Patient with ASA score \> 4; * Body mass index \< 15 or 45kg/T; * Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction * Patient refusing hypnosis * Psychic or mental Disorders * Chronic pain * Opiate therapeutic \> 3 months * Not ability to speak and read French language * Deaf and dumb patient * Under guardianship patient or guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain scale | through study completion, an average of 5 year | Pain intensity assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the pain using Visual Analogic Scale | through study completion, an average of 5 year | Reduction of the pain adverse postoperative outcome: Using Visual Analogic Scale (VAS \> 3/10) |
Countries
France
Outcome results
None listed