Clinical trial NCT03003611: Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer
Official title: Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Stage Breast Carcinoma
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient who will benefit of a surgery according a early stage of in-situ or infiltrated breast cancer

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: How is the recovering of the patient according his pain and anxiety, seven days 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: 7 days after surgery
measure: Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)?
timeFrame: 7 days post surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc - UCL
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Martine Berlière, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.