Breast Neoplasm Female
Conditions
Brief summary
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.
Interventions
BEHAVIORALPreparation in Self-Hypnosis by anchoring
Preparation in Self-Hypnosis by anchoring just before examination
BEHAVIORALConversational Hypnosis
Conversational Hypnosis during examination
BEHAVIORALPreparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in anxiety score | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | 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
| Measure | Time frame | Description |
|---|---|---|
| change in pain score | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | measured on pain visual analog scale from 0 (no pain) to 10 (worst pain) |
| patient examination experience | baseline (immediately after the intervention) | measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality) |
| staff examination experience | baseline (immediately after the intervention) | measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality) |
| change in anxiety score | baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days | measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious) |
| Amount of nesthetic administered to the patiet during the procedure | baseline (immediately after the intervention) | mL |
| Examination duration | baseline (immediately after the intervention) | minutes |
| AE/SAE reporting | baseline (during the intervention, immediatly after the intervetion) and at 8 days | — |
| anxiety score | baseline (pre-intervention) | 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. |
Countries
France
Contacts
Primary ContactVanessa MILIEN
Outcome results
None listed