Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer (HYCOREMA)

December 16, 2022 updated by: Institut de Cancérologie de Lorraine

Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bastia, France, 20600
        • CH Bastia
      • Bordeaux, France
        • Chu Bordeaux-Pellegrin
      • Brest, France
        • CHRU de Brest
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • APHM La Timone
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Vandoeuvre Les Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult patients ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Patient undergoing for a preoperative breast assessment
  • Patient must be affiliated to a social security system
  • Ability to provide an informed written consent form

Exclusion Criteria:

  • Patients diagnosed with major hearing loss
  • Patients with schizophrenia
  • Patients do not understand the French language
  • Pregnant or breast feeding females
  • Refusal of the patient to participate in the study
  • Persons deprived of liberty or under supervision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard care
Other: standard care
Patients coming for preoperative breast assessment will have standard care.
Experimental: standard care+conversational hypnosis
Other: standard care + conversational hypnosis
Patients coming for preoperative breast assessment will have standard care with conversational hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time Frame: Day 1
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the pain felt by patients during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time Frame: Day 1
The pain level will be assessed in each group by a visual analog scale from 0 to 10.
Day 1
Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
Time Frame: Day 1
The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.
Day 1
Evaluate the receptivity of women to conversational hypnosis
Time Frame: Day 1
assessment realisation time flet by patient
Day 1
Assess the impact of conversational hypnosis on completion of the examination
Time Frame: Day 1
The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: HENROT Philippe, MD, Institut de Cancérologie de Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2016

Primary Completion (Actual)

October 16, 2020

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00232-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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