Clinical trial NCT03968991: VISIODOL: Validation of the VISIODOL® Scale
Official title: VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Visual Deficiency
Congenital Blindness
Acquired Blindness
Keywords: Blinded population
Pain evaluation
Diagnostic tool
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Subjects under 18 years old
* Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)

Primary outcomes:
measure: 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.
timeFrame: Day 0 + 2 hours
Secondary outcomes:
measure: 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.
timeFrame: Day 0 + 2 hours
measure: 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 .
timeFrame: Day 0 + 2 hours
measure: 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.
timeFrame: Day 0 + 2 hours
measure: 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.
timeFrame: Day 0 + 2 hours
measure: 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.
timeFrame: Day 0 + 2 hours
measure: 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.
timeFrame: Day 0 + 2 hours
measure: Comparison of pain perception between the 3 groups
timeFrame: Day 0 + 1 hour
measure: Evaluation of the ergonomic qualities of the scale
timeFrame: Day 0 + 1 hour
measure: Evaluation of satisfaction of the use of the scale
timeFrame: Day 0 + 1 hour
measure: Evaluation of anxiety
timeFrame: Day 0 + 1 hour
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering
role: PRINCIPAL_INVESTIGATOR
References: