Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory-State Scores
研究概览
简要总结
To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (CISC) by means of an instructional video and those who do not receive specific preoperative instruction in CISC, other than basic informed consent regarding risks of postoperative urinary retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the DIvision of Urogynecology, Department of Obstetrics and Gynecology at Magee Womens Hospital.
排除标准
- •Subjects who have performed CISC in the past will be excluded.
- •Subjects whose score on the MMSE reflects dementia (<24) will be excluded.
- •Subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded.
- •Subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.
研究组 & 干预措施
Arm 1: Non-educational video self-cath
Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Arm 2: Educational Video Self-cath
Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
干预措施: Educational video (Other)
结局指标
主要结局
State-Trait Anxiety Inventory-State Scores
时间窗: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively
The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, "I feel at ease" or "I feel upset." Responses ranged from 1 to 5 from "not at all" to "very much so."
次要结局
- Patient Satisfaction Scores - Visual Analogue Scores (VAS).(Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively)