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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03370-55 | Other Identifier | 2018-A03370-55 |
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low recruits
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The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteer group | Active Comparator | male or female healthy volunteers |
|
| Subjects with acquired visual impairment | Experimental | visual acquired disability |
|
| Subjects with congenital visual impairment | Experimental | Visual congenital disability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISIODOL® (Diagnostic tool) | Diagnostic Test | Tool for assessing pain in the blind subject (with congenital or acquired deficiency) |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle Pickering | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36809402 | Derived | Pickering G, Morel V, Goubayon J, Touron A, Leray V, Pereira B. A tactile pain evaluation scale for persons with visual deficiencies. Pain Med. 2023 Jul 5;24(7):855-861. doi: 10.1093/pm/pnad013. |
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| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |