Anxiety Associated With the Use of the Electrocardiogram Function in Smart Watches

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2024-03-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Mental Health Wellness 1 Anxiety Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ECG function is enabled

Electrocardiogram (ECG) feature on the smartwatch is enabled

Group Type EXPERIMENTAL

Electrocardiogram (ECG) feature in smart watches

Intervention Type DEVICE

A study participant that is randomly assigned to the experimental group should enable the ECG function on his or her smart watch and make sure that there is synchronization with a corresponding application on his or her mobile phone. The ECG function must stay enabled, and the participant should wear the smartwatch every day for 30 days.

ECG function is not enabled

Electrocardiogram (ECG) feature on the smartwatch is not enabled

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electrocardiogram (ECG) feature in smart watches

A study participant that is randomly assigned to the experimental group should enable the ECG function on his or her smart watch and make sure that there is synchronization with a corresponding application on his or her mobile phone. The ECG function must stay enabled, and the participant should wear the smartwatch every day for 30 days.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes