Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Number of steps
研究概览
简要总结
This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients following cesarean delivery
- •Consent to participation
- •No medical recommendation for bed rest and limited mobility
- •Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker > 10 cigaretts a day, age >35, substantial limb varicose, multiple gestation, multiparity (> deliveries), emergent surgery, thrombophilia.
排除标准
- •Refusal to participate
- •Medical recommendation to limit mobility
研究组 & 干预措施
Feedback
Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve feedback regrding the number of steps taken by them at two time points.
干预措施: personalized repeated feedback approach (Other)
Control
Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve no feedback regrding the number of steps taken by them.
结局指标
主要结局
Number of steps
时间窗: 48 hours
Number of steps taken by patient as recirded by pedometer
次要结局
- Number of participants with a postpartum complication composite(48 hours)
- Number of analgesic doses(48 hours)
- Length of hospitalization(From 72 hours to one week)
- Number of thromboembolic events(Six weeks)
研究者
Hadas Ganer Herman
Principal Investigator
Wolfson Medical Center