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

Institut Cancerologie de l'Ouest225 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

225

Conditions

Breast Disease

Interventions

biopsy with audio-guided MeditationPROCEDURE

biopsy with audio-guided Meditation

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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)

Time frame: 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))

Time frame: immediately after procedure

Secondary Outcomes

per-biopsy complications

complications

Time frame: 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

Time frame: immediately after procedure

efficacy of the procedure

number of samples taken in the target

Time frame: immediately after procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes