Patient Support During Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Pain at time of procedure
研究概览
简要总结
This study will be a non-blinded randomized controlled trial (RCT) of women presenting for abortion at <13 6/7 weeks. Women will be randomized either to receive support by a trained abortion doula (intervention) or to have standard procedure (control) during the abortion procedure. The investigators hypothesize that women who receive doula support during a first trimester abortion will report less pain during the abortion procedure compared to women who do not receive abortion doula support.
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
- •Aged > 18 years
- •Gestational age by sonogram < 13 6/7 weeks gestation
- •Desires pregnancy termination
- •Ability to understand the study and give informed consent
- •Ability to read and comprehend informed consent document in English
排除标准
- •Aged < 18 years
- •Gestational age by sonogram > 13 6/7 weeks gestation
- •Inability to understand the study and give informed consent
- •Inability to read and comprehend informed consent document in English
结局指标
主要结局
Pain at time of procedure
时间窗: At time of procedure
To determine the effect of abortion doula support during a 1st trimester abortion (\< 13 6/7 wks gestational age) on the pain at the time of the abortion, as measured using a 100-mm Visual Analog Scale (VAS).
次要结局
- Satisfaction with procedure(10 minutes post-procedure)
- Pain at time of speculum insertion(At time of speculum insertion)
- Anticipated pain(Prior to procedure)
- Pre-procedure anxiety(Prior to procedure)
- Difficulty of procedure(Immediately post-procedure)
- Duration of procedure(During procedure)
- Post-procedure recalled pain(Post-procedure)