Pelvic Floor Disorder Education in the Prenatal Period, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in Prolapse and Incontinence Knowledge Questionnaire
研究概览
简要总结
Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population.
Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.
详细描述
Once verbal consent is obtained, participants will be randomly assigned in a 1:1 ratio to the intervention (video education) or control group (routine prenatal visit only). Group assignments will be performed using computer-generated randomization. All participants will complete a paper questionnaire including basic demographic information, prior history of pelvic floor disorders, and current PFD symptoms. Participants assigned to the routine prenatal visit only will be instructed to complete the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). The PIKQ is a validated 24-item questionnaire designed to assess knowledge of PFDs, including two 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
- •English-speaking
排除标准
- •Non-English-speaking patients
- •Gestational age < 37 weeks
结局指标
主要结局
Change in Prolapse and Incontinence Knowledge Questionnaire
时间窗: Baseline, 1 day ( the time of enrollment) and at 6-8 weeks
The questionnaire is divided into two separate 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP). Subscales from 0 to 12. Total scale from 0-24. A higher score indicates higher proficiency.
次要结局
未报告次要终点
研究者
Chandhana Paka
Assistant Professor
Icahn School of Medicine at Mount Sinai