VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
研究概览
简要总结
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
详细描述
The VISIODOL® monocentric study conducted at Clermont-Ferrand University Hospital is a cross-disciplinary diagnostic tool validation performed in patients with acquired or congenital visual impairment and healthy sighted volunteers. Different evaluations by thermal (Pathway Médoc®) and mechanical (electronic Von Frey®) tests will allow to compare the new VISIODOL® scale with the numerical scale, which is a commonly used tool. The ergonomic quality, the satisfaction of use and the quality of life, stress, anxiety and catastrophism of the patients will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Subjects aged over 18 / under 60
- •Male or female
- •Subjects fasting from coffee, tea, Coca-Cola and others stimulants
- •Sufficient understanding and cooperation to comply with the study requirements
- •Agreed to provide written consent
- •Affiliated to the social security
- •Subjects with visual impairment (congenital or acquired)
- •Subjects with no visual impairment (healthy group)
排除标准
- •Subjects under 18 years old
- •Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)
研究组 & 干预措施
Subjects with congenital visual impairment
Visual congenital disability
干预措施: VISIODOL® (Diagnostic tool) (Diagnostic Test)
Healthy volunteer group
male or female healthy volunteers
干预措施: VISIODOL® (Diagnostic tool) (Diagnostic Test)
Subjects with acquired visual impairment
visual acquired disability
干预措施: VISIODOL® (Diagnostic tool) (Diagnostic Test)
结局指标
主要结局
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
时间窗: Day 0 + 2 hours
Determination of the correlation coefficient between NS and VISIODOL® scale for different pain temperatures by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
次要结局
- Evaluation of satisfaction of the use of the scale(Day 0 + 1 hour)
- Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.(Day 0 + 2 hours)
- Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.(Day 0 + 2 hours)
- Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests .(Day 0 + 2 hours)
- Comparison of pain perception between the 3 groups(Day 0 + 1 hour)
- Evaluation of the ergonomic qualities of the scale(Day 0 + 1 hour)
- Evaluation of anxiety(Day 0 + 1 hour)