Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Measure of physiologic stress of patients and staff
研究概览
简要总结
Patients will be randomly assigned to one of two groups: the group exposed to NS, or the standard care group exposed to supportive dialogue. Patients assigned to the former group will be exposed to continuous NS throughout the CNB procedure.
详细描述
For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient positioning and breast compression is complete, (2) One 2-min local anesthesia administration period during which the skin is injected with local anesthetic and an incision is made to insert the biopsy needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia administration period during which imaging is obtained to confirm the position of the needle with respect to the target, (4) One 1-minute sampling period when the breast tissue is sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained samples is confirmed and the need for additional sampling determined, and (6) One 2-minute period during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.
For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient is positioning, (2) One 2-min local anesthesia administration period during which local anesthesia is given at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local anesthesia administration period during which intra-procedure imaging and confirmation of adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during which the biopsy device is advanced to the target for the first time and fired to acquire the first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6) One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.
The total time for a single site CNB is approximately 30 minutes when performed under US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added physiological recordings for this experiment are not expected to significantly prolong the duration of CNB procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1) ≥ 21 years old
- •2) present for CNB
- •3) to be able to read and speak English
- •4) provide written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Nature sounds exposure
Patients will be randomly assigned to either the nature sounds group or the standard care group.
Patients in the nature sounds group will be exposed to continuous nature sounds during the core needle biopsy (CNB) procedure.
The CNB procedure will continue as planned with nature sounds playing instead of the supportive dialogue. All sounds will be played out of a speaker situated in the corner of the room.
干预措施: Nature sounds (Other)
Standard care (supportive dialogue)
Patients will be randomly assigned to either the nature sounds group or the standard care group.
The CNB procedure will continue as planned with supportive dialogue which will be played out of a speaker situated in the corner of the room. This group follows the current standard of care.
结局指标
主要结局
Measure of physiologic stress of patients and staff
时间窗: From the start of procedure until the end, not to exceed 2 years.
Parasympathetic activity will be measured by HF HRV in patients and staff. Descriptive statistics from these measurements will be calculated and compared across the two groups.
Measure of psychologic stress of patients and staff
时间窗: From the start of procedure until the end, not to exceed 2 years.
Patients and staff will be required to complete a questionnaire. Questions are organized so to capture levels of psychologic stress. The answers will be compared across the two groups and descriptive statistics will be calculated.
次要结局
未报告次要终点