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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003611
Other study ID # ONCO-GYNECO 2014/1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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