Breast Cancer Clinical Trial
— HYPNOSEINOfficial title:
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
Verified date | August 2020 |
Source | Institut du Cancer de Montpellier - Val d'Aurelle |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 22, 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Institut réginal du Cancer de Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of pain scale | Pain intensity assessment | through study completion, an average of 5 year | |
Secondary | Reduction of the pain using Visual Analogic Scale | Reduction of the pain adverse postoperative outcome: Using Visual Analogic Scale (VAS > 3/10) |
through study completion, an average of 5 year |
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