Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

Study Overview
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Brief Summary
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The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.

Official Title
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Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study

Conditions
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Breast Neoplasm Female

Intervention / Treatment
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* Behavioral: Preparation in Self-Hypnosis by anchoring
* Behavioral: Conversational Hypnosis
* Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 or over, referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy, naive of any hypnosis, having given free, informed and written consent, being affiliated to a social security scheme or beneficiary of such scheme Exclusion Criteria: having a major hearing loss, suffering from identified mental or psychotic disorders, not understanding the French language, having already had hypnosis practices, having an ongoing pregnancy, being the subject of a safeguard measure

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: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>control | |
| Experimental: Preparation in Self-Hypnosis by anchoring<br>1-hour consultation with a hypnopractor just before the examination | Behavioral: Preparation in Self-Hypnosis by anchoring<br>* Preparation in Self-Hypnosis by anchoring just before examination<br>|
| Experimental: Conversational Hypnosis<br>conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained | Behavioral: Conversational Hypnosis<br>* Conversational Hypnosis during examination<br>|
| Experimental: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis<br>1-hour consultation with a hypnopractor just before the examination and conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained | Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis<br>* Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in anxiety score | Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment. Total scores can be categorized into five levels: > 65 (very high), from 56 to 65 (high), from 46 to 55 (medium), from 36 to 45 (low), < 35 (very low). Higher scores mean a worse outcome. | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in anxiety score | measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious) | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | 
| change in pain score | measured on pain visual analog scale from 0 (no pain) to 10 (worst pain) | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | 
| patient examination experience | measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality) | baseline (immediately after the intervention) | 
| staff examination experience | measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality) | baseline (immediately after the intervention) | 
| anxiety score | STAI-Y2 (score from 20 to 80 measured on the STAI for trait anxiety), how respondent generally feel Total scores can be categorized into five levels: > 65 (very high), from 56 to 65 (high), from 46 to 55 (medium), from 36 to 45 (low), < 35 (very low). Higher scores mean a worse outcome. | baseline (pre-intervention) | 
| Amount of nesthetic administered to the patiet during the procedure | mL | baseline (immediately after the intervention) | 
| Examination duration | minutes | baseline (immediately after the intervention) | 
| AE/SAE reporting |  | baseline (during the intervention, immediatly after the intervetion) and at 8 days |