Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

Breast Cancer Clinical Trial

— HYCOREMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02867644
• Other study ID #: 2016-A00232-49
• Status: Terminated
• Phase: N/A
• Start date: November 17, 2016
• Est. completion date: October 16, 2020

Study information

• Verified date: December 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 171
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• standard care
Patients coming for preoperative breast assessment will have standard care.
• standard care + conversational hypnosis
Patients coming for preoperative breast assessment will have standard care with conversational hypnosis

Locations

Country	Name	City	State
France	CH Bastia	Bastia
France	Chu Bordeaux-Pellegrin	Bordeaux
France	CHRU de Brest	Brest
France	Centre Léon Bérard	Lyon
France	APHM La Timone	Marseille
France	Centre Paul Strauss	Strasbourg
France	Institut de Cancerologie de Lorraine	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

Lemoine L, Adam V, Galus X, Siles P, Coulon A, Grenier-Desforges J, Orabona J, Kergastel I, Wagner P, Salleron J, Tosti P, Huin-Schohn C, Merlin JL, Etienne R, Henrot P. Conversational hypnosis versus standard of care to reduce anxiety in patients undergo — View Citation

Outcome

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