Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure
研究概览
简要总结
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
详细描述
audio-guided meditation during breast biopsy procedures questionnaires (STAI-ETAT and EN) before and after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast pathology requiring the performance of one (or more) breast and/or axillary micro or macrobiopsy,
- •Informed patient, with collection of the non opposition
排除标准
- •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).
结局指标
主要结局
To describe anxiety according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure
时间窗: 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))
To describe the level of pain according to whether or not patients listen to audio-guided mediation during the breast biopsy procedure
时间窗: immediately after procedure
11-point numerical scale (from 0 = no pain to 10 = maximal pain)
次要结局
- satisfaction of the radiologist with regard to the procedure(immediately after procedure)
- per-biopsy complications(immediately after procedure (same day of the biopsy))
- efficacy of the procedure(immediately after procedure)