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临床试验/NCT02758561
NCT02758561已完成不适用

2015 Motivational Interviewing in Women's Pelvic Wellness Education Project

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).

研究概览

简要总结

This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.

详细描述

Pelvic floor disorders can significantly affect a woman's quality of life, yet many feel uncomfortable openly discussing these topics. Treatments include lifestyle modification, medications, and/or surgery. "Decisional conflict" arises when patients have difficulty choosing between several viable treatment options. Factors contributing to decisional conflict include biased information, poor peer support, and unaddressed fears. Effective counselling may help address these factors.

There are few studies on how decision coaching can help women with prolapse and incontinence reach a satisfactory decision about treatment. This study aims to use the principals of shared decision making to address decisional conflict surrounding treatment for pelvic floor disorders. Specifically, the investigators will evaluate the feasibility and acceptability of small group workshops on pelvic organ prolapse and urinary incontinence led by a nurse continence advisor and a psychologist (decision coach).

Results of this study will inform future development of interdisciplinary, patient-centered approaches to enhanced decision making in women's health.

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
Single (Outcomes Assessor)

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

  • Women ages >18 years old
  • Urinary incontinence and/or pelvic organ prolapse
  • First visit with urogynecologist

排除标准

  • Anal incontinence
  • Previous pelvic radiation therapy
  • Requirement for a Substitute Decision Maker
  • Inability to attend the workshop
  • Unwilling to attend an English-language workshop
  • Unwilling to complete English-language surveys

结局指标

主要结局

Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).

时间窗: The Decisional Conflict Scale (DCS), will be administered to participants in the control and intervention groups at baseline and first follow up visit, approx. 3 months later.

The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.

次要结局

  • Participant satisfaction with the workshop.(This will be measured using a survey administered to participants immediately following the workshop)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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