Breast Disease
Conditions
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.
Interventions
PROCEDUREbiopsy with audio-guided Meditation
biopsy with audio-guided Meditation
Sponsors
Institut Cancerologie de l'Ouest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe the level of pain according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure | immediately after procedure | 11-point numerical scale (from 0 = no pain to 10 = maximal pain) |
| To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure | immediately after 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| per-biopsy complications | immediately after procedure (same day of the biopsy) | complications |
| satisfaction of the radiologist with regard to the procedure | immediately after procedure | questions about 1. overall quality of the doctor-patient relationship and 2. Patient compliance with the procedure with scales in 4 point |
| efficacy of the procedure | immediately after procedure | number of samples taken in the target |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre BERGE, MD
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed