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临床试验/NCT03436888
NCT03436888已完成不适用

Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Disability

研究概览

简要总结

The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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 from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

排除标准

  • Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.

结局指标

主要结局

Disability

时间窗: up to ten days

Disability will be measured using Pelvic Girdle Questionnaire

次要结局

  • Disability: Oswestry disability index(1 day (First appointment))
  • fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire(1 day (First appointment))
  • Pain Catastrophizing: Pain catastrophizing scale(1 day (First appointment))
  • Pain: Visual Analogue Pain Rating Scale(1 day (First appointment))
  • health-related quality of life: SF 8 scale(1 day (First appointment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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