Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our patient population, undergoing IUD insertion/EMB procedure at the end of our study.
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
- 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
- 否
入选标准
- •present for an IUD insertion procedure and/or for EMB procedure.
排除标准
- •current Pelvic inflammatory disease (PID)
- •contraindications to IUD or EMB
- •malignancy
- •contraindication to hydroxyzine/Lidocaine/Benzocaine
- •positive pregnancy test
研究组 & 干预措施
Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed
干预措施: Paracervical block- Lidocaine without epinephrine (Drug)
Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed
干预措施: Hydroxyzine Hydrochloride (Drug)
Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed
干预措施: Benzocaine Gel applied to the cervix (Drug)
Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed
干预措施: Hydroxyzine Hydrochloride (Drug)
No analgesia with Hydroxyzine hydrochloride if needed
干预措施: Hydroxyzine Hydrochloride (Drug)
结局指标
主要结局
Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS)
时间窗: baseline (with the speculum in place before pain management procedures), after tenaculum placement (but before IUD placement or EMB) and immediately after IUD insertion or EMB.
VAS is scored from 1-10, higher score indicating greater pain
次要结局
- Change in anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale(baseline, and after taking Hydroxyzine about 15-30 mins before procedure)
研究者
Pamela Berens
Professor
The University of Texas Health Science Center, Houston