Clinical trial · Interventional
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation (Virtual Reality) in the Breast Oncologic Surgery
- 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)
The aims of the study are to compare the recovering period between a group of patients with conventional sedation, a group using hypnosis as sedation during the surgery and a third group using hypnosis as a relaxation method and preparation but enjoying a classic sedation for their surgery. Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up. Comparisons are also performed in substudies defined by treatments modalités. Inflammatory parameters s ( CRP\_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Procedure | — | UNRESOLVED |
| General anesthesia with preoperative session of hypnosis | Procedure | — | UNRESOLVED |
| Hypnosis sedation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- General anesthesia
- description
- Patients will undergo oncologic breast surgery on general anesthesia.
- interventionNames
- Procedure: General anesthesia
- type
- EXPERIMENTAL
- label
- Hypnosis sedation
- description
- Patients will undergo oncologic breast surgery on hypnosis sedation.
- interventionNames
- Procedure: Hypnosis sedation
- type
- EXPERIMENTAL
- label
- General anesthesia with preoperative session of hypnosis
- description
- Patients interested in hypnosis but too anxious to have surgery while on hypnosis sedation will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation using technology of virtual reality
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patient over 18 years old * Signed informed consent form * Patient has to be in possession of her administrative laws and affiliated to the social security insurance. * The patient must have a diagnosis of resectable breast cancer (in situ or invasive breast cancer). . Surgical procedure must include evaluation of the axillary area (sentinel lymph node biopsy and or axillary dissection) Exclusion Criteria: * Patient under 18 years old * No signed informed consent form * Patients who haven't her social security insurance and prisoners are not eligible. * No evaluation of the axillary area. * Breast cancer in men
References
Publications (0)
Data not yet available