VISIODOL: Validation of the VISIODOL® Scale (VISIODOL)

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

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

Study Overview

• Status: Terminated
• Conditions: Visual Deficiency; Congenital Blindness; Acquired Blindness
• Intervention / Treatment: Diagnostic test: VISIODOL® (Diagnostic tool)

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Blinded population; Pain evaluation; Diagnostic tool
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness
• Other Study ID Numbers: RBHP 2018 PICKERING 2; 2018-A03370-55 (Other Identifier: 2018-A03370-55)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No