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

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

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).

Study Overview

• Status: Completed
• Conditions: Early Stage Breast Carcinoma
• Intervention / Treatment: Procedure: hypnose sedation; Procedure: general anesthesia

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc - UCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

patient who will benefit of a surgery according a early stage of in-situ or infiltrated breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypnose; the group of patient who's operated under hypnose sedation	Procedure: hypnose sedation; Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
traditional 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.	Procedure: general anesthesia; Patient will be anesthetized with a classical general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Study Director: Martine Berlière, MD PhD, Cliniques universitaires Saint-Luc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ONCO-GYNECO 2014/1