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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Preparation in Self-Hypnosis by anchoring just before examination
Conversational Hypnosis during examination
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
Hôpital Saint Joseph
Marseille, France
RECRUITINGchange 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: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 35 (very low). Higher scores mean a worse outcome.
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
change in anxiety score
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 35 (very low). Higher scores mean a worse outcome.
Time frame: baseline (pre-intervention)
Amount of nesthetic administered to the patiet during the procedure
mL
Time frame: baseline (immediately after the intervention)
Examination duration
minutes
Time frame: baseline (immediately after the intervention)
AE/SAE reporting
Time frame: baseline (during the intervention, immediatly after the intervetion) and at 8 days
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