The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Saint Antoine questionnaire to measure perceived pain at day 4 post-partum
研究概览
简要总结
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.
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
- 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
- •Major women
- •Giving birth vaginally in the maternity of Geneva university hospital
- •First and second degree perineal tears or episiotomy
- •French speaking women
- •The day of the delivery
排除标准
- •Allergic to honey and bees
- •postpartum hemorrhage
结局指标
主要结局
Saint Antoine questionnaire to measure perceived pain at day 4 post-partum
时间窗: Day 4
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum
时间窗: Day 1
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum
时间窗: Day 4
A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
Saint Antoine questionnaire to measure perceived pain at day 1 post-partum
时间窗: Day 1
Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.
次要结局
- Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1(Day 4)
- Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum(Day 4)
- Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum(Day 1)
研究者
Marie-Julia GUITTIER
Associate Professor
University Hospital, Geneva