Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
audio-guided meditation during breast biopsy procedures questionnaires (STAI-ETAT and EN) before and after the procedure.

Official Title
-----------------
Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures

Conditions
-----------------
Breast Disease

Intervention / Treatment
-----------------
* Procedure: biopsy with audio-guided Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast pathology requiring the performance of one (or more) breast and/or axillary micro or macrobiopsy, Informed patient, with collection of the non opposition Exclusion Criteria: Excluded forms of the disease: biopsy concerning organs other than the breast and/or axilla Persons deprived of their liberty, under court protection, under curatorship or under the authority of a guardian, Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons (invalidating psychiatric disorder diagnosed of psychotic type).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: biopsy with audio-guided Meditation|biopsy with audio-guided Meditation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | immediately after procedure | 
| efficacy of the procedure | number of samples taken in the target | immediately after procedure |