Clinical trial NCT02867644: Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer
Official title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: conversational hypnosis
imaging
care
breast neoplasia
anxiety
pain
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
timeFrame: Day 1
Secondary outcomes:
measure: 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)
timeFrame: Day 1
measure: Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)
timeFrame: Day 1
measure: Evaluate the receptivity of women to conversational hypnosis
timeFrame: Day 1
measure: Assess the impact of conversational hypnosis on completion of the examination
timeFrame: Day 1
Other outcomes:
Locations:
city: Bastia
country: France
facility: CH Bastia
city: Bordeaux
country: France
facility: Chu Bordeaux-Pellegrin
city: Brest
country: France
facility: CHRU de Brest
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: APHM La Timone
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre Les Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: HENROT Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 undergoing marker placement under radiographic control prior to breast cancer surgery: A randomized, multicenter trial. Front Psychol. 2022 Nov 22;13:971232. doi: 10.3389/fpsyg.2022.971232. eCollection 2022.