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

Early Stage Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003611
• Other study ID #: ONCO-GYNECO 2014/1
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: November 9, 2017
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Stage Breast Carcinoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc - UCL	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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 : Anxiety (will be mesured by the anxiety visual scale); Pain (mesured by analogic visual pain scale); 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).	One day after the surgery
Secondary	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.	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 : Anxiety (will be mesured by the anxiety visual scale); Pain (mesured by analogic visual pain scale); 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).	7 days after surgery
Secondary	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)?	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.	7 days post surgery