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

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

Study Overview

• Status: Completed
• Conditions: Breast Disease
• Intervention / Treatment: Procedure: biopsy with audio-guided Meditation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de Cancérologie de l'Ouest (ICO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Pierre BERGE, MD, Institut de cancerologie de l'ouest

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: ICO-2021-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No