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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04040608
Other study ID # RNI 2018 DUTHEIL 3
Secondary ID 2018-A03280-55
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2021
Est. completion date March 2026

Study information

Verified date February 2024
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Visual analog scales (VAS) are one of the most common tools used in questionnaires. VAS are validated for pain and stress for example on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100). Nowadays, most VAS are used on questionnaires on internet. However, the influence of screen sizes on responses to visual analog scales were never studied.


Description:

Visual analog scales (VAS) are one of the most common tools used in questionnaires. VAS are validated for pain and stress for example on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100). Nowadays, most VAS are used on questionnaires on internet. However, the influence of screen sizes on responses to visual analog scales were never studied. Primary objective is to study the influence of screen sizes on response responses to visual analog scales. Secondary objectives are to assess: - the variability of responses depending on screen sizes within a week - the influence of perception of work and addiction to work on the variability depending on screen sizes - relationships with biomarkers of stress : salivary DHEAS, heart rate variability and skin conductance An open questionnaire will be created by the Clinical Research Direction. The questionnaire will be opened by the examinator who will fulfill the anonymized identification of participants and the type of screens. In a dedicated room at the LaPSCo, the participants will answer the same VAS on four different sizes/types of screens (24-inch screen, laptop, tablet, smartphone) and on paper. Saliva will be collected after answering questionnaires. Heart rate variability and skin conductance will be measured with the use of a wrist watch during 15 minutes, from the entrance in the room to the completion of questionnaires. The participant will undergo the same examination within a week (15 minutes).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult persons Exclusion Criteria: - Refusal to participate in the study - Unable to answer basic questions (difficulties understanding, cognitive disorders…)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Influence of screen sizes on responses to visual analog scales of stress
An open questionnaire will be created by the Clinical Research Direction. The questionnaire will be opened by the examinator who will fulfill the anonymized identification of participants and the type of screens. In a dedicated room at the LaPSCo, the participants will answer the same VAS on four different sizes/types of screens (24-inch screen, laptop, tablet, smartphone) and on paper. Saliva will be collected after answering questionnaires. Heart rate variability and skin conductance will be measured with the use of a wrist watch during 15 minutes, from the entrance in the room to the completion of questionnaires. The participant will undergo the same examination within a week (15 minutes).

Locations

Country Name City State
France Chu Clermont Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Institut de Médecine du Travail, UMR CNRS 6024, LaPSCo

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale to assess the perceived stress Visual analog scale to assess the perceived stress on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) day 0
Primary Visual analog scale to assess the perceived stress Visual analog scale to assess the perceived stress on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) day 7
Secondary Visual analog scale to assess anxiety Visual analog scale to assess anxiety on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) day 0, day 7
Secondary Visual analog scale to assess sleep quality Visual analog scale to assess sleep quality on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) day 0, day 7
Secondary Visual analog scale to assess fatigue Visual analog scale to assess fatigue on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) day 0, day 7
Secondary Job Demand-Control-Support (JDSC) questionnaire of Karasek The Job Demand-Control-Support (JDSC) questionnaire of Karasek assessed job demands, job control and social support through 26 items. day 0, day 7
Secondary The Effort-Reward Imbalance Questionnaire (ERI) The Effort-Reward Imbalance Questionnaire (ERI) is a self-administrated test assessing psychological distress and health problems that may occur when there is an imbalance between the efforts required by the work and the rewards received. day 0, day 7
Secondary The Work Addiction Risk Test (WART) The Work Addiction Risk Test (WART) was developed by Robinson et al. from symptoms reported by clinicians caring for patients with work addiction day 0, day 7
Secondary Hospital Anxiety and Depression (HAD) Scale Hospital Anxiety and Depression (HAD) Scale is a self-reported questionnaire composed of 14 items with a 4-point Likert scale assessing anxiety (7 items) and/or depressive (7 items) symptoms day 0, day 7
Secondary The Maslach Burn-out Inventory (MBI) The Maslach Burn-out Inventory (MBI) is composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items) day 0, day 7
Secondary Heart rate variability Heart rate variability and skin conductance will be measured with the use of the wristband Empatica E4, Italy day 0, day 7
Secondary : skin conductance Heart rate variability and skin conductance will be measured with the use of the wristband Empatica E4, Italy day 0, day 7
Secondary Salivary DHEAS Salivary DHEAS is a biomarker of chronic stress, with a long half-life of 16 hours day 0, day 7
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