Clinical trial · Interventional
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
NCT03253159CI-TRIAL-00046533HYPNOSEINcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypnosis group
- description
- The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room
- interventionNames
- Behavioral: Hypnosis
- type
- NO_INTERVENTION
- label
- Control group
- description
- No special preparation before intravenous general anesthesia induction in the operative room
Primary outcomes (1)
- measure
- Assessment of pain scale
- timeFrame
- through study completion, an average of 5 year
- description
- Pain intensity assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAmraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164. PMID 30646110