Validation of the French Version of the Pain Sensitivity Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- The psychometric properties of the French version of the PSQ
研究概览
简要总结
The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. These questions simulate daily life situations likely to induce pain of various intensities. The internal validity of the tool had been demonstrated both for the original version in German, and then for its English version. The external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (German version), and to patients before surgery (English version). A French validation of the questionnaire is needed, in order to integrate it in pain research programs in French-speaking countries.
详细描述
The aim is to validate the French version of the PSQ in a 2-step plan : (i) validity of internal structure, convergent validity and reproducibility, in a sample of patients before scheduled surgery, and (ii) structure and convergent validity against external criterion, in healthy volunteers. A secondary objective is to study the relationship of scores of the PSQ with a scale assessing sensitivity to natural smells, noise and light sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
open
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 18 to 65, currently French-speaking and able to answer questionnaires, undergoing a pre-anesthetic mandatory visit, either for scheduled surgery, or as a follow-up of pregnancy
- •healthy volunteers aged 18 to 60, currently French-speaking and able to answer questionnaires, BMI 19 to 30 kg/m2, free from any medication since 7 days before each study session, covered by the French welfare health system.
排除标准
- •are : risk of pregnancy, any medical history or condition likely to impair participation or quality of outcome measurement, any ongoing relevant disease, any cutaneous lesion at nondominant forearm, any ocular, neurological or acoustic contra-indication to the tests, spontaneous tinnitus or disease with hyperacusia, anxiety or depression with score >11 on HAD, addiction to drugs or alcohol abuse, inclusion in a concomitant trial, French legal protection
- •Exclusion Criteria:
研究组 & 干预措施
scheduled surgery
干预措施: Psychophysical exploration (Behavioral)
healthy volunteers
干预措施: Psychophysical exploration (Behavioral)
结局指标
主要结局
The psychometric properties of the French version of the PSQ
时间窗: at day 1
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
次要结局
- The natural smell sensitivity assessed independently by a home-made questionnaire(at day 1)
- The natural noise sensitivity assessed independently by a home-made questionnaire(at day 1)
- The natural light sensitivity, assessed independently by a home-made questionnaire(at day 1)