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

NCT ID: NCT05343975

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-11-02

Brief Summary

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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

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

Conditions

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Breast Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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biopsy with audio-guided Meditation

biopsy with audio-guided Meditation

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre BERGE, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT DE CANCEROLOGIE DE L'OUEST

Locations

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Institut de Cancerologie de L'Ouest (Ico)

Angers, , France

Site Status

Countries

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France

Other Identifiers

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ICO-2021-31

Identifier Type: -

Identifier Source: org_study_id

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