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

Breast Disease Clinical Trial

— MAG-BM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343975
• Other study ID #: ICO-2021-31
• Status: Completed
• Start date: March 2, 2022
• Est. completion date: November 2, 2023

Study information

• Verified date: August 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: November 2, 2023
• Est. primary completion date: November 1, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Disease
• Breast Diseases

Intervention

Procedure:
• biopsy with audio-guided Meditation
biopsy with audio-guided Meditation

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest (Ico)	Angers 02

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	per-biopsy complications	complications	immediately after procedure (same day of the biopsy)
Secondary	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
Secondary	efficacy of the procedure	number of samples taken in the target	immediately after procedure