An Educational Video to Improve Patient Comprehension of Midurethral Sling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Felicia Lane
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Patient knowledge questionnaire (investigator-created)
研究概览
简要总结
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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
- •Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital
排除标准
- •< 18 years of age
- •Non-English speaking or requiring interpreter assistance
- •Presence of cognitive dysfunction
- •Women receiving a repeat midurethral sling (not primary)
- •Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
- •Pregnant women
研究组 & 干预措施
Intervention
The intervention group will be shown an educational video
干预措施: Educational video (Other)
Control
The control group will be given an educational leaflet
干预措施: Educational leaflet (Other)
结局指标
主要结局
Patient knowledge questionnaire (investigator-created)
时间窗: 6 weeks
The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.
次要结局
未报告次要终点
研究者
Felicia Lane
Professor, Urogynecology Division Director
University of California, Irvine