Influence of Screen Sizes on Responses to Visual Analog Scales of Stress

Volunteers Clinical Trial

— SIVAStress  

Official title:

Influence of Screen Sizes on Responses to Visual Analog Scales of Stress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040608
• Other study ID #: RNI 2018 DUTHEIL 3
• Secondary ID: 2018-A03280-55
• Status: Recruiting
• 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
• 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…)

Related Conditions & MeSH terms

• Volunteers

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