A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •IUI must be performed in the Reproductive Endocrinology and Infertility offices at Mayo Clinic in Rochester.
- •IUI procedure must be on a weekday.
- •IUI procedure is scheduled to be completed by a nurse in the REI Department.
排除标准
- •Not English speaking.
- •IUI procedure on a weekend day.
- •IUI procedure is scheduled with an MD provider (known or expected to be difficult).
- •Planned IUI procedure is cancelled prior to undergoing the procedure.
- •The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
- •The patient has previous participated or declined enrollment in the study during a prior IUI procedure.
结局指标
主要结局
Change in anxiety
时间窗: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "No anxiety" on the left, and "Worst anxiety" on the right. Participants will identify their anxiety level by indicating a point on the line between each end. That point will be measured from the "No anxiety" end, and the number of millimeters will be reported as the pain score.
次要结局
- Change in pain score(Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes))
- Pregnancy rate(1 year)
研究者
Alessandra (Ali) J. Ainsworth
Principal Investigator
Mayo Clinic