Clinical trial · Observational
Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer
Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer
- 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 investigators will compare the operated patients for a beginning breast cancer in the Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational study as we cannot randomized patient, (they need to be compliant with Hypnose). Patient will be informed that some parameters, about his recovery, will be collected from their medical file. They will not have another particular treatment because they are in the study. It is just a prospective data collection. The patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) Also the investigators will compare the impact of hypnose on the other treatments the patient received. The investigators need approximately 150 patients (Half in each arm).
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 |
|---|---|---|---|
| Early Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| general anesthesia | Procedure | — | UNRESOLVED |
| hypnose sedation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hypnose
- description
- the group of patient who's operated under hypnose sedation
- interventionNames
- Procedure: hypnose sedation
- label
- traditional anesthesia
- description
- The match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery.
- interventionNames
- Procedure: general anesthesia
Primary outcomes (1)
- measure
- How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
- timeFrame
- One day after the surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent Form * In situ breast cancer (early stage) * Infiltrated Breast cancer (early stage) Exclusion Criteria: * No hypnoses is possible for this patient surgery
References
Publications (1)
- DERIVEDBerliere M, Roelants F, Watremez C, Docquier MA, Piette N, Lamerant S, Megevand V, Van Maanen A, Piette P, Gerday A, Duhoux FP. The advantages of hypnosis intervention on breast cancer surgery and adjuvant therapy. Breast. 2018 Feb;37:114-118. doi: 10.1016/j.breast.2017.10.017. Epub 2017 Nov 11. PMID 29136523