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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

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE November 17, 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two differents procedures (standard care versus standard care with conversational hypnosis) [ Time Frame: 1 day ]
The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.
Change History Complete list of historical versions of study NCT02867644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • 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.
  • 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.
  • Evaluate the receptivity of women to conversational hypnosis [ Time Frame: Day 1 ]
    assessment realisation time flet by patient
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Compare the pain felt by patients during a preoperative breast marking under ultrasound according two differents procedures (standard care versus standard care with conversational hypnosis) [ Time Frame: 1day ]
    The pain level will be assessed in each group by a visual analog scale from 0 to 10.
  • Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two differents procedures (standard care versus standard care with conversational hypnosis) [ Time Frame: 1 day ]
    The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.
  • Evaluate the receptivity of women to conversational hypnosis [ Time Frame: 1 day ]
    assessment realisation time flet by patient
  • Assess the impact of conversational hypnosis on completion of the examination [ Time Frame: 1 day ]
    The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer
Official Title  ICMJE Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Other: standard care
    Patients coming for preoperative breast assessment will have standard care.
  • Other: standard care + conversational hypnosis
    Patients coming for preoperative breast assessment will have standard care with conversational hypnosis
Study Arms  ICMJE
  • Active Comparator: standard care
    Intervention: Other: standard care
  • Experimental: standard care+conversational hypnosis
    Intervention: Other: standard care + conversational hypnosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
334
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867644
Other Study ID Numbers  ICMJE 2016-A00232-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut de Cancérologie de Lorraine
Study Sponsor  ICMJE Institut de Cancérologie de Lorraine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: HENROT Philippe, MD Institut de Cancérologie de Lorraine
PRS Account Institut de Cancérologie de Lorraine
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP