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临床试验/NCT01987440
NCT01987440已完成不适用

Effect of Lubricating Gel for Pain Relief During Speculum Examination in Gynecologic Oncology Patients

Erzincan Military Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Pelvic examination, an important part of gynecologic oncology patients to help detect cancers recurrence or infections.Despite its importance, many women are reluctant and anxious about the procedure because of fear, as well as discomfort and pain. The objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water in gynecologic oncology patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • *Female patients WHO came for surveillance for malignant gynecologic disease such as uterine cancer, cervix cancer, and ovarian cancer with or without radiotherapy and chemotherapy
  • Exclusion Criteria
  • Women were undergoing Vulvectomy or Vaginectomy
  • Women with narrow vagina for standard medium size of speculum for examination
  • Women who underwent fertility sparing surgery.
  • Women had vaginitis

排除标准

  • 未提供

研究组 & 干预措施

Lubricating Gel

Experimental

The speculum was warmed, and patients were informed about what was going to happen. The labia were spread from below to introduce the speculum, which was inserted at a 45-degree angle pointing downward then rotated horizontally as the insertion continued. A VAS score (insertion) was obtained at this point. Next, the bill of the speculum was opened up until the vaginal cuff could be seen, and the speculum was secured by turning the thumbnut. A second VAS score (dilation) was recorded. During speculum examination, cervical smear with cervical brush was obtained for pathologic assessment if necessary. The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained. In the gel group , a doctor placed 6,5 mL mL sterile lubricating gel on the top and bottom blades of the speculum. Length of the vagina was measured by the index finger.

干预措施: lubricating gel (Drug)

water

Placebo Comparator

A VAS score (insertion) was obtained at this point. Next, the bill of the speculum was opened up until the vaginal cuff could be seen, and the speculum was secured by turning the thumbnut. A second VAS score (dilation) was recorded. During speculum examination, cervical smear with cervical brush was obtained for pathologic assessment if necessary. The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained. In the water group the speculum's top and bottom blades were moistened with 6,5 mL tap water previously loaded into a syringe kept at room temperature.After the speculum examination, pelvic examination was performed and length of the vagina (defined as distance from vaginal cuff to vaginal apex) was measured by the index finger.

干预措施: lubricating gel (Drug)

结局指标

主要结局

Visual Analog Scale

时间窗: During Speculum Examination Dilatation stage

During Speculum Examination Dilatation stage

次要结局

  • visual analog scale insertion stage(uring Speculum Examination insertion stage)

研究者

发起方
Erzincan Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kemal GUNGORDUK

M.D

Erzincan Military Hospital

研究点 (1)

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