Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures (MAG-BM)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Breast Disease

Treatments: Procedure: biopsy with audio-guided Meditation

Study type: Observational

Funder types: Other

Identifiers

NCT05343975

ICO-2021-31

Details and patient eligibility

About

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

Full description

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

Enrollment: 225 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).