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

Completed

• Conditions: Early Stage Breast Carcinoma
• Interventions: Procedure: hypnose sedation; Procedure: general anesthesia

• Registration Number: NCT03003611
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-28
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypnose	hypnose sedation	the group of patient who's operated under hypnose sedation
traditional anesthesia	general 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.

Primary Outcome Measures

Name	Time	Method
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.	One day after the surgery	We'll collect the following information in the standard medical file : The collected measures who will analyzed are anxiety, pain and consumption of analgesic.; Items : 1. Anxiety (will be mesured by the anxiety visual scale); 2. Pain (mesured by analogic visual pain scale); 3. consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).

Secondary Outcome Measures

Name	Time	Method
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.	7 days after surgery	We'll collect the following information in the standard medical file : The collected measures who will analyzed are anxiety, pain and consumption of analgesic.; Items : 1. Anxiety (will be mesured by the anxiety visual scale); 2. Pain (mesured by analogic visual pain scale); 3. consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
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)?	7 days post surgery	We'll collect the following information in the standard medical file : * Redness of the skin : yes /no; * Delay in the scar process : yes/ no; * Infection: yes/ no; * Hypertrophie of the scar : yes/no; * Pain : Yes/No After analysis of the parameters, we will determine a good scar healing process, or not.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc - UCL; 🇧🇪 Brussels, Belgium