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临床试验/NCT04436354
NCT04436354已完成不适用

The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2018年11月1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
157
试验地点
1
主要终点
Visual Analog Score for pain

研究概览

简要总结

The present study revealed that the TL position is supposed to be more efficient not only for lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in this position may be easier for doctors than in the lithotomy position.

详细描述

VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of the study was to enlighten the gap in the literature regarding the pain score and procedural time during VOH for diagnostic purposes in TL position. In order to gain scientific evidence, a randomized controlled trial was conducted to compare pain score and duration of procedure between the standard lithotomy position and TL position. Also, the convenience for the physician performing the procedure was assessed. To the best of our knowledge, this is the first study in the literature investigating the effect of the position of the patient during the procedure on both time, pain, and the convenience for the physician simultaneously.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •uterine disorders
  • •abnormal uterine bleeding
  • •infertility

排除标准

  • •pregnancy
  • •cervical disorders
  • •pelvic infections

研究组 & 干预措施

vaginoscopic office hysteroscopy in the trendelenburg position

Experimental

干预措施: vaginoscopic office hysteroscopy (Procedure)

vaginoscopic office hysteroscopy in lithotomy position

Experimental

干预措施: vaginoscopic office hysteroscopy (Procedure)

结局指标

主要结局

Visual Analog Score for pain

时间窗: 12 months

The Visual Pain Scale (VPS) was used to evaluate pain levels with 0 represented pain-free, while 10 described the most severe pain (Ekin et al. 2009; Price et al. 1983). Patients were asked to mark the pain expressing point on the VPS immediately after VOH. The severity of pain is determined by the value of the point (cm) marked by the participant

procedural times

时间窗: 12 months

minutes

次要结局

  • attitudinal Likert type survey(12 months)

研究者

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

Fatma ketenci gencer

Principle investigator

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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