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

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ClinicalTrials.gov Identifier: NCT02867644
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: standard care Other: standard care + conversational hypnosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
Actual Study Start Date : November 17, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Evaluate the receptivity of women to conversational hypnosis [ Time Frame: Day 1 ]
    assessment realisation time flet by patient

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867644


Contacts
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Contact: MERLIN Jean Louis 00 33 3 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: FERNANDES Laurinda 0033383598487 l.fernandes@nancy.unicancer.fr

Locations
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France
CH Bastia Recruiting
Bastia, France, 20600
Contact: Joseph ORABONA, MD         
Chu Bordeaux-Pellegrin Recruiting
Bordeaux, France
Contact: Jeannette GRENIER-DESFORGES, MD         
CHRU de Brest Recruiting
Brest, France
Contact: Isabelle KERGASTEL, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Agnes COULON, MD         
APHM La Timone Recruiting
Marseille, France
Contact: SILES Pascale, MD         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Wagner Pierre, MD         
Institut de Cancerologie de Lorraine Recruiting
Vandoeuvre Les Nancy, France, 54519
Contact: HENROT PHILIPPE, MD       p.henrot@nancy.unicancer.fr   
Contact: LEMOINE LYDIE       l.lemoine@nancy.unicancer.fr   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: HENROT Philippe, MD Institut de Cancérologie de Lorraine

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02867644     History of Changes
Other Study ID Numbers: 2016-A00232-49
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:
conversational hypnosis
imaging
care
breast neoplasia
anxiety
pain

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases