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

NCT05343975 | Completed

• 1 other identifier: ICO-2021-31
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• per-biopsy complications

  immediately after procedure (same day of the biopsy)

• satisfaction of the radiologist with regard to the procedure

  immediately after procedure

• efficacy of the procedure

  immediately after procedure

Interventions

biopsy with audio-guided Meditation PROCEDURE

biopsy with audio-guided Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Breast pathology requiring the performance of one (or more) breast and/or axillary micro or macrobiopsy,
• Informed patient, with collection of the non opposition

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest (Ico)

Angers, 49055, France

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre BERGE, MD

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 25, 2022
• Study Start: March 2, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 2, 2023
• Last Updated: February 13, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)