Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

Study Overview
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Brief Summary
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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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: standard care
* Other: standard care + conversational hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard care<br> | Other: standard care<br>* Patients coming for preoperative breast assessment will have standard care.<br>|
| Experimental: standard care+conversational hypnosis<br> | Other: standard care + conversational hypnosis<br>* Patients coming for preoperative breast assessment will have standard care with conversational hypnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Evaluate the receptivity of women to conversational hypnosis | assessment realisation time flet by patient | Day 1 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain