Clinical trial NCT06131463: Anxiety Associated With the Use of the Electrocardiogram Function in Smart Watches
Official title: Assessing the Impact of Using the Electrocardiogram Function in Smart Watches on the Level of Anxiety (GAD-7) Among University Students and Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Anxiety Disorders
Depression
Keywords: Anxiety
Depression
ECG
Smartwatch
Randomized trial
Lead sponsor: ITMO University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 71
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Anxiety level
timeFrame: 30 days
Secondary outcomes:
measure: Depression
timeFrame: 30 days
measure: Depression
timeFrame: 90 days
measure: Anxiety level
timeFrame: 90 days
measure: Heart rhythm disturbances
timeFrame: 90 days
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: ITMO University
Study officials:
affiliation: ITMO University
name: Liubov Maliugina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
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citation: Rosman L, Gehi A, Lampert R. When smartwatches contribute to health anxiety in patients with atrial fibrillation. Cardiovasc Digit Health J. 2020 Jul-Aug;1(1):9-10. doi: 10.1016/j.cvdhj.2020.06.004. Epub 2020 Aug 28. No abstract available.
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