Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: standard care; Other: standard care + conversational hypnosis

• Registration Number: NCT02867644
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2016-11-17
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard care	-
standard care+conversational hypnosis	standard care + conversational hypnosis	-

Primary Outcome Measures

Name	Time	Method
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)	Day 1	The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.

Secondary Outcome Measures

Name	Time	Method
Evaluate the receptivity of women to conversational hypnosis	Day 1	assessment realisation time flet by patient
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)	Day 1	The pain level will be assessed in each group by a visual analog scale from 0 to 10.
Assess the impact of conversational hypnosis on completion of the examination	Day 1	The assessment will be evaluated in each group by the radiologist according to 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)	Day 1	The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.

Trial Locations

Locations (7)

CH Bastia; 🇫🇷 Bastia, France

Chu Bordeaux-Pellegrin; 🇫🇷 Bordeaux, France

CHRU de Brest; 🇫🇷 Brest, France

APHM La Timone; 🇫🇷 Marseille, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut de Cancerologie de Lorraine; 🇫🇷 Vandoeuvre Les Nancy, France