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临床试验/NCT05633901
NCT05633901进行中(未招募)不适用

Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery

TriHealth Inc.4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
160
试验地点
4
主要终点
Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.

研究概览

简要总结

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

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
Single (Investigator)

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

  • Prolapse surgery may include: apical repair with uterosacral ligament suspension, or sacrospinous/iliococcygeal ligament fixation, or sacrocolpopexy.
  • They may also have a concomitant total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy, other compartment repairs for prolapse, or a suburethral sling for incontinence.
  • Surgery by one of the fellowship trained Urogynecologists at TriHealth
  • Age >= 18
  • English speaking
  • Able to comprehend and answer the survey completely.

排除标准

  • Concomitant procedure with another surgeon
  • Resides in a nursing home
  • Non-English speaking
  • Patients with mental disability, Alzheimer's disease, dementia that would preclude complete answering of the survey or inability to answer the questions.

结局指标

主要结局

Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.

时间窗: Immediately Pre-op

Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

次要结局

  • To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety(Immediately Pre-op)
  • To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients that did or did not watch the video at home(Immediately Pre-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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