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临床试验/NCT02761382
NCT02761382已完成不适用

Mindfulness-based Psychological Pain Treatment in Endometriosis

University of Aarhus5 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年3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
58
试验地点
5
主要终点
Pelvic pain measured on Numeric Rating Scale

研究概览

简要总结

This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).

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
None

入排标准

年龄范围
18 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Endometriosis diagnosed by laparoscopy or MRI.
  • Moderate to severe endometriosis-related chronic pelvic pain.
  • Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.

排除标准

  • Fibromyalgia, Colitis Chron or Colitis Ulcerosa
  • Severe psychiatric diagnosis
  • Pregnancy or planned pregnancy during the study period

结局指标

主要结局

Pelvic pain measured on Numeric Rating Scale

时间窗: Change from pre-intervention to post-intervention (12 weeks)

Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.

次要结局

  • Pain acceptance measured by Chronic Pain Acceptance Questionnaire(Change from pre-intervention to post-intervention (12 weeks))
  • Work Ability measured by the Work Ability Index(Change from pre-intervention to post-intervention (12 weeks))
  • Endometriosis related symptoms measured on Numeric Rating Scale(Change from pre-intervention to post-intervention (12 weeks))
  • Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)(Change from pre-intervention to post-intervention (12 weeks))
  • Quality of life measured by the Endometriosis Health Profile 30 questionnaire(Change from pre-intervention to post-intervention (12 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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