Skip to main content
OpenTrials
Completed

NCT Number: NCT03003611

Observational Trial on the Impact of Hypnose Used as a Sedation in 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Early Stage Breast Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc - UCL

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnose sedation

Procedure

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

General Anesthesia

Procedure

Patient will be anesthetized with a classical general anesthesia

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.

    Time frame: 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 :

    • 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).

Secondary outcomes

  1. 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.

    Time frame: 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 :

    • 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).

  2. 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)?

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2016
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.