About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
having a major hearing loss,
suffering from identified mental or psychotic disorders,
not understanding the French language,
having already had hypnosis practices,
Trial design
Sequential
Treatments tested in this trial
Preparation in Self-Hypnosis by anchoring
BehavioralPreparation in Self-Hypnosis by anchoring just before examination
Conversational Hypnosis
BehavioralConversational Hypnosis during examination
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
BehavioralPreparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
Treatment groups
Trial outcomes
Primary outcomes
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: 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.
Secondary outcomes
change in anxiety score
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
change in pain score
measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)
patient examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
staff examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Sponsors and contacts
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