- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040608
Influence of Screen Sizes on Responses to Visual Analog Scales of Stress (SIVAStress)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont Ferrand
-
Principal Investigator:
- Frédéric DUTHEIL
-
Contact:
- Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult persons
Exclusion Criteria:
- Refusal to participate in the study
- Unable to answer basic questions (difficulties understanding, cognitive disorders…)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
experimental group
differences in responses to visual analog scales depending on screen sizes
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale to assess the perceived stress
Time Frame: day 0
|
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
|
|
Visual analog scale to assess the perceived stress
Time Frame: day 7
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale to assess anxiety
Time Frame: day 0, day 7
|
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
|
|
Visual analog scale to assess sleep quality
Time Frame: day 0, day 7
|
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
|
|
Visual analog scale to assess fatigue
Time Frame: day 0, day 7
|
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
|
|
Job Demand-Control-Support (JDSC) questionnaire of Karasek
Time Frame: day 0, day 7
|
The Job Demand-Control-Support (JDSC) questionnaire of Karasek assessed job demands, job control and social support through 26 items.
|
day 0, day 7
|
|
The Effort-Reward Imbalance Questionnaire (ERI)
Time Frame: day 0, day 7
|
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
|
|
The Work Addiction Risk Test (WART)
Time Frame: day 0, day 7
|
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
|
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: day 0, day 7
|
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
|
|
The Maslach Burn-out Inventory (MBI)
Time Frame: day 0, day 7
|
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
|
|
Heart rate variability
Time Frame: day 0, day 7
|
Heart rate variability and skin conductance will be measured with the use of the wristband Empatica E4, Italy
|
day 0, day 7
|
|
: skin conductance
Time Frame: day 0, day 7
|
Heart rate variability and skin conductance will be measured with the use of the wristband Empatica E4, Italy
|
day 0, day 7
|
|
Salivary DHEAS
Time Frame: day 0, day 7
|
Salivary DHEAS is a biomarker of chronic stress, with a long half-life of 16 hours
|
day 0, day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: frédéric Dutheil, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RNI 2018 DUTHEIL 3
- 2018-A03280-55 (Other Identifier: 2018-A03280-55)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Volunteers
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
McMaster UniversityOntario Ministry of Health and Long Term Care; Canadian Red Cross; David BraleyCompleted
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
Clinical Trials on Influence of screen sizes on responses to visual analog scales of stress
-
Assiut UniversitySouth Egypt Cancer InstituteActive, not recruitingAcute Lymphoblastic Leukemia ALLEgypt
-
University of California, DavisCompleted