Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Cesarean Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Daily average postoperative pain scores
研究概览
简要总结
Cesarean delivery is a common obstetrical procedure and is associated with increased maternal morbidity and mortality. Pain and limited mobilization are major contributing factors that result in delayed functional recovery and complications. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not been properly examined.
The aim of this study is to examine the effect of postcesarean elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to support incisional site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women undergoing cesarean delivery
排除标准
- •Cesarean hysterectomy
- •Intraoperative accidental injury to urinary or gastrointestinal organs
- •Postoperative admission to intensive care unit (ICU)
- •Postoperative intraperitoneal drain placement
- •Unable to understand and follow oral/written instructions
- •Severe neuromuscular or circulatory disorders
- •Pulmonary diseases
研究组 & 干预措施
Binder
Each woman will be fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder will be placed snuggly tight on top of the hospital gown at the infraumbilical level with the incision positioned at the middle part of the binder. The patients will be encouraged to wear binders at all time. However, periods of break from wearing the binder will be allowed at their convenience.
干预措施: Elastic abdominal binder (Device)
No binder
The women will not be given a chance to wear abdominal binder or the likes.
结局指标
主要结局
Daily average postoperative pain scores
时间窗: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
A visual analog scale pain score
Postoperative functional recovery
时间窗: In the morning of postoperative day 3
Six-minute walk test (6MWT)
次要结局
- Quality of life(In the morning of postoperative day 3)
- Postoperative complications(In the morning, up to 7 days postoperation)
研究者
Kittipat Charoenkwan, MD
Associate Professor
Chiang Mai University