Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer
NCT ID: NCT03003611
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2014-04-30
2016-09-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hypnose
the group of patient who's operated under hypnose sedation
hypnose sedation
Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
traditional anesthesia
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.
general anesthesia
Patient will be anesthetized with a classical general anesthesia
Interventions
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hypnose sedation
Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
general anesthesia
Patient will be anesthetized with a classical general anesthesia
Eligibility Criteria
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Inclusion Criteria
* In situ breast cancer (early stage)
* Infiltrated Breast cancer (early stage)
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Martine Berlière, MD PhD
Role: STUDY_DIRECTOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
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Cliniques universitaires Saint-Luc - UCL
Brussels, , Belgium
Countries
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References
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Berliere 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.
Other Identifiers
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ONCO-GYNECO 2014/1
Identifier Type: -
Identifier Source: org_study_id