Validation of a Female Pelvic Floor Interactive Training Model: RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology
研究概览
简要总结
Residents increase their knowledge of female pelvis anatomy using a pelvic floor interactive model methodology (Pelvic+) compared to the traditional methodology.
详细描述
Objectives:
- To evaluate the residents' knowledge of the female pelvis anatomy at 3 months post intervention.
- To determine residents' satisfaction with Pelvic+ methodology compared to traditional methodology.
Material and Method:
Design: A multicentre, two arms, parallel randomized controlled trial (RCT) of an educational intervention to compare knowledge on female pelvis anatomy between Pelvic+ methodology and traditional methodology at baseline, at completion of intervention and at 3 months post-intervention.
Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Principal investigator and the statistician will remain blind to group allocation. Outcome assessments will only be conducted by principal investigator blind to the intervention and control groups.
Second researcher and professor will remain blind to questions included in both questionnaires: anatomy and satisfaction.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •midwives in their 1st year of training and who wish to participate and sign the informed consent document.
排除标准
- •registered midwives,
- •residents who have previously undertake another residence
- •residents who have done their Final Work Grade on pelvic floor,
- •residents who have done pelvic dissection during their grade studies
- •traditional methodology using anatomical models.
结局指标
主要结局
Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology
时间窗: 15 months
The primary outcome of change of knowledge of the female pelvis anatomy at three months post-intervention with Pelvic+ methodology compared to traditional methodology will be measured by a self-completed questionnaire that will be completed by participants in both control and intervention groups prior to the teaching session and then three months post teaching. The following five anatomical topics will be researched: 1. bone structure and obstetrical landmarks 2. ligament structure 3. superficial perineal muscle 4. deep pelvis muscle 5. nerves. Each of the above anatomical topics will be assessed with three questions using a Likert type scale, the total mean scores for each of the anatomical topics pre teaching and at three months post teaching for both the intervention and control groups will then be compared and analysed for comparison between the intervention and control goups.
次要结局
- Satisfaction with Pelvic+ methodology compared to traditional methodology(1 year)
研究者
Ana Pereda
Gynecologist
Universitat Autonoma de Barcelona