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Completed

NCT Number: NCT05343975

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

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

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Key information

Conditions

Breast Disease Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest (Ico)

Angers, 49055, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

biopsy with audio-guided Meditation

Procedure

biopsy with audio-guided Meditation

Primary outcomes

  1. To describe the level of pain according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure

    Time frame: immediately after procedure

    11-point numerical scale (from 0 = no pain to 10 = maximal pain)

  2. To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure

    Time frame: 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 outcomes

  1. per-biopsy complications

    Time frame: immediately after procedure (same day of the biopsy)

    complications

  2. satisfaction of the radiologist with regard to the procedure

    Time frame: 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

  3. efficacy of the procedure

    Time frame: immediately after procedure

    number of samples taken in the target

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: MAG-BM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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