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临床试验/NCT07325994
NCT07325994招募中不适用

Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
92
试验地点
1
主要终点
pain during OH

研究概览

简要总结

Office hysteroscopy is a cornerstone in the diagnostic evaluation of infertile women, enabling direct visualization of the uterine cavity for identifying intrauterine pathology. The vaginoscopic ("no-touch") approach, which eliminates the use of a speculum and tenaculum, is increasingly adopted due to improved tolerability, higher success rates, and reduced pain compared to conventional methods.

详细描述

Office hysteroscopy is a cornerstone in the diagnostic evaluation of infertile women, enabling direct visualization of the uterine cavity for identifying intrauterine pathology. The vaginoscopic ("no-touch") approach, which eliminates the use of a speculum and tenaculum, is increasingly adopted due to improved tolerability, higher success rates, and reduced pain compared to conventional methods.

Despite this, many women still report moderate to severe pain, particularly during cervical passage and uterine distension. High pain scores may result in incomplete examinations, decreased patient satisfaction, and increased need for sedation or analgesia. Various pharmacological interventions have been studied, including NSAIDs, local anesthetics, and misoprostol, with inconsistent or limited benefit.

Verbal analgesia, a structured communication strategy involving calm, supportive, and reassuring verbal cues, has been shown to reduce procedural pain in other gynecologic settings such as IUD insertion. However, no randomized trial has specifically evaluated structured verbal analgesia in women with primary infertility undergoing vaginoscopic office hysteroscopy. This trial aims to address this evidence gap by comparing verbal analgesia with standard neutral communication, with both groups receiving baseline NSAID premedication.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • o Women aged 18-40 years.
  • Diagnosis of primary infertility (failure to conceive after ≥12 months of unprotected intercourse).
  • Indication for diagnostic office hysteroscopy.
  • Regular menstrual cycles.

排除标准

  • o Secondary infertility.
  • Known pelvic infection, cervicitis, or vaginitis.
  • Use of analgesics within 8 hours prior to procedure.
  • Cervical stenosis, prior failed hysteroscopy, or known uterine anomaly.
  • Contraindication to NSAIDs
  • Pregnancy or suspected pregnancy.

结局指标

主要结局

pain during OH

时间窗: During the procedure (immediately after insertion of hysteroscope, assessed within 5 minutes

It will be measured by 0-10 numerical rating scale where 0 indicates no pain and 10 worst pain imaginable

次要结局

  • Patient satisfaction(At the end of the visit (within 30 minutes of procedure completion))

研究者

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

Ahmed Samy aly ashour

Clinical Professor

Cairo University

研究点 (1)

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