Assessing the Impact of Using the Electrocardiogram Function in Smart Watches on the Level of Anxiety (GAD-7) Among University Students and Employees
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mental Health Wellness 1
- Sponsor
- ITMO University
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Anxiety level
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The integration of electrocardiography (ECG) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. However, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups.
Some smart device manufacturers do not recommend using the ECG function for anyone under the age of 22. However, young people are frequent users of wearable devices. One of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal.
That said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety.
This study will assess the level of psycho-emotional health (anxiety level) of the study participants. Participant observation will provide an opportunity to identify associations between the use of the ECG recording function on wearable devices and levels of anxiety and depression. It is hypothesized that the use of smartwatches with the ECG function activated will not lead to a change in anxiety levels on the GAD-7 scale among the study participants. This assumes that after 30 days of use, the mean value of the GAD-7 scale in the intervention group and the control group will be the same.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Status of a student or employee of ITMO University;
- •Availability of a smart watch with ECG function (Apple Watch Series 4 and newer, Galaxy Watch Active2, Samsung Galaxy Watch Series 3 and newer or similar with ECG function);
- •Availability of a Galaxy smartphone running Android 7.0 or newer or availability of an iPhone 8 and newer smartphone with the latest version of iOS.
- •Signed Informed consent and Consent for Data Processing of Personal Data;
- •Absence of previously diagnosed clinically significant cardiovascular pathology.
Exclusion Criteria
- •Participants under the age of 22 cannot be included in the study;
- •Participants in the acute phase of any disease or in the exacerbation of chronic diseases are excluded from the study.
Outcomes
Primary Outcomes
Anxiety level
Time Frame: 30 days
Anxiety level is measured 30 days after the enrolment with Generalized Anxiety Disorder 7-item (GAD-7) which is a tool based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
Secondary Outcomes
- Heart rhythm disturbances(90 days)
- Depression(90 days)
- Anxiety level(90 days)