Status:
COMPLETED
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03253159
Start Date
September 1 2014
End Date
February 22 2017
Last Update
August 10 2020
Active Locations (1)
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1
Institut réginal du Cancer de Montpellier
Montpellier, France, 34298