Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures
NCT ID: NCT05343975
Last Updated: 2026-02-13
Study Results
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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COMPLETED
225 participants
OBSERVATIONAL
2022-03-02
2023-11-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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biopsy with audio-guided Meditation
biopsy with audio-guided Meditation
Eligibility Criteria
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Inclusion Criteria
* Informed patient, with collection of the non opposition
Exclusion Criteria
* 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).
18 Years
FEMALE
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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ICO-2021-31
Identifier Type: -
Identifier Source: org_study_id
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