VISIODOL: Validation of the VISIODOL® Scale

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

Detailed Description
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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.

Official Title
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VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment

Conditions
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Visual Deficiency, Congenital Blindness, Acquired Blindness

Intervention / Treatment
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* Diagnostic Test: VISIODOL® (Diagnostic tool)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy volunteer group<br>male or female healthy volunteers | Diagnostic Test: VISIODOL® (Diagnostic tool)<br>* Tool for assessing pain in the blind subject (with congenital or acquired deficiency)<br>|
| Experimental: Subjects with acquired visual impairment<br>visual acquired disability | Diagnostic Test: VISIODOL® (Diagnostic tool)<br>* Tool for assessing pain in the blind subject (with congenital or acquired deficiency)<br>|
| Experimental: Subjects with congenital visual impairment<br>Visual congenital disability | Diagnostic Test: VISIODOL® (Diagnostic tool)<br>* Tool for assessing pain in the blind subject (with congenital or acquired deficiency)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 0 + 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10. | 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 . | Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10. | 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. | Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10. | 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. | Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by electronic Von Frey®. The rating of the NS and VISIODOL® scales can range from 0 to 10. | 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. | Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10. | 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. | Determination of the correlation coefficient between NS and VISIODOL® scale for tolerance threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10. | Day 0 + 2 hours | 
| Comparison of pain perception between the 3 groups | comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®). | Day 0 + 1 hour | 
| Evaluation of the ergonomic qualities of the scale | ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire. | Day 0 + 1 hour | 
| Evaluation of satisfaction of the use of the scale | satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire. | Day 0 + 1 hour | 
| Evaluation of anxiety | Hospital and Anxiety Depression Scale (HAD) : The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42. | Day 0 + 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blinded population, Pain evaluation, Diagnostic tool