Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer (HYCOREMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02867644|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: standard care Other: standard care + conversational hypnosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||334 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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
- 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.
- 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.
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
|Contact: MERLIN Jean Louis||00 33 3 83 59 83 email@example.com|
|Contact: FERNANDES Laurindafirstname.lastname@example.org|
|Bastia, France, 20600|
|Contact: Joseph ORABONA, MD|
|Contact: Jeannette GRENIER-DESFORGES, MD|
|CHRU de Brest||Recruiting|
|Contact: Isabelle KERGASTEL, MD|
|Centre Léon Bérard||Recruiting|
|Contact: Agnes COULON, MD|
|APHM La Timone||Recruiting|
|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 email@example.com|
|Contact: LEMOINE LYDIE firstname.lastname@example.org|
|Principal Investigator:||HENROT Philippe, MD||Institut de Cancérologie de Lorraine|