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临床试验/NCT05259800
NCT05259800终止不适用

Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention

TriHealth Inc.2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年10月5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
17
试验地点
2
主要终点
Percent of Patients With Urinary Retention Resolved

研究概览

简要总结

A randomized controlled study will be conducted, with two arms. Postpartum women experiencing urinary retention will be randomized into one of the two following arms:

  • Arm 1: Subjects will be exposed to vapor of peppermint oil
  • Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

详细描述

The purpose of the study is to determine if the use of peppermint oil among postpartum women experiencing urinary retention will increase spontaneous urination and decrease the need for catheterization. A randomized controlled study will be conducted, with two arms. Subjects will be randomized into one of the two following arms:

  • Arm 1: Subjects will be exposed to vapor of peppermint oil
  • Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

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

入选标准

  • 1. 18 years old or older
  • English speaking
  • Admitted to Bethesda North Mom Baby Unit
  • Experiencing urinary retention - defined as meeting at least one of the following criteria:
  • More than 6 hours after delivery or foley catheter removal without being able to spontaneously void
  • Symptomatic urinary retention without being able to spontaneously void
  • Change in fundal height or position without being able to spontaneously void
  • Bladder scan showing bladder containing 400mL or more urine

排除标准

  • Allergy to peppermint
  • Active herpes lesions
  • Seizure disorder
  • Not able to void in toilet (ex: requiring use of bed pan to void)

研究组 & 干预措施

Peppermint Oil

Experimental

Subjects will be exposed to vapor of peppermint oil

干预措施: Peppermint oil vapors (Other)

结局指标

主要结局

Percent of Patients With Urinary Retention Resolved

时间窗: 10 minutes

Urinary retention defined as: * More than 6 hours after delivery or foley catheter removal without being able to spontaneously void * Symptomatic urinary retention without being able to spontaneously void * Change in fundal height or position without being able to spontaneously void More than 6 hours after delivery or foley catheter removal without voiding spontaneously; symptomatic urinary retention without being able to spontaneously void; or change in fundal height or position without being able to spontaneously void Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil

Percent of Patients With Urinary Retention Resolved

时间窗: 10 minutes

Urinary retention defined as: * More than 6 hours after delivery or foley catheter removal without being able to spontaneously void * Symptomatic urinary retention without being able to spontaneously void * Change in fundal height or position without being able to spontaneously void More than 6 hours after delivery or foley catheter removal without voiding spontaneously; symptomatic urinary retention without being able to spontaneously void; or change in fundal height or position without being able to spontaneously void Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil

次要结局

  • Time to Spontaneous Urination(1 hour)
  • Volume of Spontaneous Urination(1 hour)
  • Incidence of Urinary Catheterization(1 hour)
  • Patient Satisfaction(1 hour)
  • Time to Spontaneous Urination(1 hour)
  • Volume of Spontaneous Urination(1 hour)
  • Incidence of Urinary Catheterization(1 hour)
  • Patient Satisfaction(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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