Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | control | |
| Preparation in Self-Hypnosis by anchoring | Experimental | 1-hour consultation with a hypnopractor just before the examination |
|
| Conversational Hypnosis | Experimental | conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained |
|
| Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparation in Self-Hypnosis by anchoring | Behavioral | Preparation in Self-Hypnosis by anchoring just before examination |
|
| 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:
| baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa MILIEN | Contact | 0488731070 | vmilien@hopital-saint-joseph.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph | Recruiting | Marseille | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conversational Hypnosis | Behavioral | Conversational Hypnosis during examination |
|
| Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis | Behavioral | Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination |
|
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:
| 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 |