Acquired Blindness Clinical Trial
— VISIODOLOfficial title:
VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment
| Verified date | January 2022 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
| Status | Terminated |
| Enrollment | 37 |
| Est. completion date | December 28, 2020 |
| Est. primary completion date | December 28, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Clermont Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |