跳至主要内容
临床试验/NCT05191238
NCT05191238终止不适用

Patients Pull the Strings: A Pilot Study of IUD Self-Removal Simulation

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2022年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
37
试验地点
1
主要终点
Change in proportion of participants who are willing to attempt IUD self-removal

研究概览

简要总结

This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Patients will be recruited for this study at the time of presentation to the office for IUD removal. After consenting to the procedure, participants will complete a pre-intervention survey, watch a video explaining how to self-remove the IUD, and use two models to simulate IUD removal. After completion of using the models to practice IUD removal, participants will complete a second short survey. The participant will then be given the option of attempting self-removal and be given time to attempt the removal. If the participant elects to have the provider remove their IUD, the provider will do so. At the end of the encounter, participants will fill out a final survey. Research staff will measure the length of the strings of all IUDs prior to routine disposal of the device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •English or Spanish speaking
  • •Present to Boston Medical Center Yawkey for removal of IUD and have been consented for removal
  • •Are eligible for removal of IUD in the office setting

排除标准

  • •Current incarceration

研究组 & 干预措施

Participants consented for IUD removal

Experimental

Participants will be shown an educational video about IUD self-removal and simulation models. After the video, participants will be given the choice to either attempt IUD self-removal or to have their provider perform standard removal. If a participant elects to attempt self-removal and fails, their provider will offer standard removal.

干预措施: IUD self-removal education (Other)

结局指标

主要结局

Change in proportion of participants who are willing to attempt IUD self-removal

时间窗: baseline, 15-30 minutes

Participants will be asked before and after reviewing the educational video and practicing self-removal through simulation, if they are willing to attempt IUD self-removal. The change in the proportion willing to attempt IUD self-removal will be calculated.

Proportion of participants who attempt IUD self-removal

时间窗: 15-30 minutes

Attempt Yes/No

次要结局

  • Success of IUD self removal(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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