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临床试验/NCT03400540
NCT03400540已完成不适用

What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?

University of Haifa2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年1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
已完成
入组人数
56
试验地点
2
主要终点
urinary bladder displacement in millimeters during first verbal instruction

研究概览

简要总结

The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound.

详细描述

This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment.

A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort.

The participants will be divided into 2 groups randomly. Both groups will be given three different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound.

To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • willing to participate in the study

排除标准

  • pregnancy
  • previous abdominal surgeries

研究组 & 干预措施

Group A

Experimental

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

  1. "squeeze the pelvic floor muscles"
  2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"
  3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."
  4. "contract all of the above together"

干预措施: verbal instruction (Diagnostic Test)

Group B

Experimental

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

  1. "squeeze the pelvic floor muscles"
  2. "squeeze the anus"
  3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."
  4. "contract all of the above together"

干预措施: verbal instruction (Diagnostic Test)

结局指标

主要结局

urinary bladder displacement in millimeters during first verbal instruction

时间窗: up to 6 months

bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

urinary bladder displacement in millimeters during second verbal instruction

时间窗: up to 6 months

bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

urinary bladder displacement in millimeters during third verbal instruction

时间窗: up to 6 months

bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

次要结局

  • demographic self reported questionnaire regarding height(baseline)
  • questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form(baseline)
  • BMI(baseline)
  • pelvic floor muscles endurance of contraction in seconds(up to 6 months)
  • demographic self reported questionnaire regarding weight(baseline)
  • self reported questionnaire regarding physical activity(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gali Dar

principal investigator

University of Haifa

研究点 (2)

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