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

NCT03003611 | Completed DMC

• 1 other identifier: ONCO-GYNECO 2014/1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Early Stage Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 : 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).

  One day after the surgery

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Hypnose

the group of patient who's operated under hypnose sedation

Procedure: hypnose sedation

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

Interventions

hypnose sedation PROCEDURE

Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia

Hypnose

general anesthesia PROCEDURE

Patient will be anesthetized with a classical general anesthesia

traditional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Signed informed consent Form
• In situ breast cancer (early stage)
• Infiltrated Breast cancer (early stage)

You may not qualify if:

• No hypnoses is possible for this patient surgery

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc - UCL

Brussels, 1200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 29136523 DERIVED

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Martine Berlière, MD PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: December 28, 2016
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 13, 2017

Record last verified: 2016-12

Locations

BE (1)