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A prospective, non-randomized, single-center cohort study to evaluate the value of audio-guided meditation during breast biopsy procedures.
The main criterion of judgment is based on the evaluation of tolerance, which includes anxiety and pain felt. This is assessed with questionnaires (STAI-ETAT and EN) before and after the procedure.
Secondary endpoints include tolerance of additional physical pain, reduction in the number of per-procedure complications, overall satisfaction of the practitioner with the biopsy procedure, and comparison of the tolerance of the procedure in patients who practice meditation at home before the procedure
audio-guided meditation during breast biopsy procedures questionnaires (STAI-ETAT and EN) before and after the procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy with audio-guided Meditation | Procedure | biopsy with audio-guided Meditation |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the level of pain according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure | 11-point numerical scale (from 0 = no pain to 10 = maximal pain) | immediately after procedure |
| To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure | State Trait Anxiety Inventory Etat - Trait (40 questions - each item has a score from 1 to 4 (4 being the highest level of anxiety)) | immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| per-biopsy complications | complications | immediately after procedure (same day of the biopsy) |
| satisfaction of the radiologist with regard to the procedure | questions about 1. overall quality of the doctor-patient relationship and 2. Patient compliance with the procedure with scales in 4 point |
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Inclusion Criteria:
Exclusion Criteria:
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Women referred to the ICO of Angers for management of a breast pathology, or during screening, requiring the performance of one (or more) breast micro or macrobiopsy.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre BERGE, MD | INSTITUT DE CANCEROLOGIE DE L'OUEST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de L'Ouest (Ico) | Angers | 49055 | France |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| immediately after procedure |
| efficacy of the procedure | number of samples taken in the target | immediately after procedure |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |