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Terminated

NCT Number: NCT03968991

VISIODOL: Validation of the VISIODOL® Scale

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

Why the study stopped: low recruits
Terminated

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Key information

Conditions

Visual Deficiency Acquired Blindness Blindness Congenital Blindness Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VISIODOL® (Diagnostic tool)

Diagnostic Test

Tool for assessing pain in the blind subject (with congenital or acquired deficiency)

Primary outcomes

  1. 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.

    Time frame: Day 0 + 2 hours

    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.

Secondary outcomes

  1. 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.

    Time frame: Day 0 + 2 hours

    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.

  2. 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 .

    Time frame: Day 0 + 2 hours

    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.

  3. 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.

    Time frame: Day 0 + 2 hours

    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.

  4. 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.

    Time frame: Day 0 + 2 hours

    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.

  5. 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.

    Time frame: Day 0 + 2 hours

    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.

  6. 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.

    Time frame: Day 0 + 2 hours

    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.

  7. Comparison of pain perception between the 3 groups

    Time frame: Day 0 + 1 hour

    comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®).

  8. Evaluation of the ergonomic qualities of the scale

    Time frame: Day 0 + 1 hour

    ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire.

  9. Evaluation of satisfaction of the use of the scale

    Time frame: Day 0 + 1 hour

    satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire.

  10. Evaluation of anxiety

    Time frame: Day 0 + 1 hour

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: VISIODOL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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