Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Early Stage Breast Carcinoma

Treatments: Procedure: general anesthesia; Procedure: hypnose sedation

Study type: Observational

Funder types: Other

Identifiers

NCT03003611

ONCO-GYNECO 2014/1

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Hypnose

Description:

the group of patient who's operated under hypnose sedation

Treatment:

Procedure: hypnose sedation

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.

Treatment:

Procedure: general anesthesia