Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for Pain
研究概览
简要总结
The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.
详细描述
The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future.
Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.
Secondary endpoints
- Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
- Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
- Discuss participant's experiences with taking lorazepam and participating in the study
- Assess investigator's experience with the trial via a focus group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
- •Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
- •Participants must have a driver take them home after the procedure as well.
- •Participants must consent to email communication since they will sign the consent forms electronically
排除标准
- •Participants who do not show up for their appointment.
- •Participants who receive cervical blocks or other analgesic method during IUD insertion.
- •Participants who have a history of substance use disorder.
- •Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
- •Participants who are not able to sign an electronic consent form.
- •Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
- •Participants who do not agree to sign consent forms electronically.
研究组 & 干预措施
Lorazepam administration prior to IUD insertion procedure
干预措施: Lorazepam 1 mg (Drug)
Lorazepam administration prior to IUD insertion procedure
干预措施: Ibuprofen 800 mg (Drug)
结局指标
主要结局
Visual Analogue Scale for Pain
时间窗: before and after the procedure (up to 1 hour)
Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).
Visual Analogue Scale for Anxiety
时间窗: before and after the procedure (up to 1 hour)
Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety).
次要结局
- Mean Anxiety Scores for Nulliparous and Multiparous Participants(before and after the procedure (up to 1 hour))
- Number of Participants Recruited(up to 2 months (estimated time period of recruitment))
- Number of Participants Who Completed All Surveys(up to 2 months (estimated time period of recruitment))
- Mean Pain Scores for Nulliparous and Multiparous Participants(before and after the procedure (up to 1 hour))
- Number of Participants with lorazepam prescription adherence(up to 2 months (estimated time period of recruitment))
- Qualitative Measure: Participant Experience(post-procedure (up to 1 hour))