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临床试验/NCT06969365
NCT06969365Enrolling By Invitation1 期

Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?

Saint Luke's Health System2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
1 期
状态
Enrolling By Invitation
入组人数
54
试验地点
2
主要终点
Visual Analog Scale - Anxiety

研究概览

简要总结

When having an intrauterine device placed in an outpatient clinic, patients frequently feel anxiety related to the procedure. This study is designed to determine if the use of a small, weighted blanket, placed over the patient's chest and shoulders, would help decrease that anxiety, as well as pain related to the procedure.

详细描述

Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • scheduled for IUD placement
  • age 18 years or older
  • able to read and understand English and use a pen

排除标准

  • inability to consent
  • inability to remove weighted blanket

结局指标

主要结局

Visual Analog Scale - Anxiety

时间窗: At the conclusion of the procedure

Patients will make a mark on a 100 mm line to indicate level of anxiety

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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