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Completed

NCT Number: NCT06131463

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

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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Key information

Conditions

Mental Health Wellness 1 Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

22 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ITMO University

Saint Petersburg, 197101, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrocardiogram (ECG) feature in smart watches

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.

Primary outcomes

  1. 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

  1. Depression

    Time frame: 30 days

    Depression is assessed 30 days after the enrolment with Patient Health Questionnaire-9 (PHQ-9) that can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).

  2. Depression

    Time frame: 90 days

    Depression is assessed 90 days after the enrolment with Patient Health Questionnaire-9 (PHQ-9) that can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).

  3. Anxiety level

    Time frame: 90 days

    Anxiety level is measured 90 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.

  4. Heart rhythm disturbances

    Time frame: 90 days

    The frequency of detection of clinically significant and clinically insignificant heart rhythm disturbances.

Sponsors and collaborators

Lead sponsor

ITMO University

Other

Registry information

Official study title

Assessing the Impact of Using the Electrocardiogram Function in Smart Watches on the Level of Anxiety (GAD-7) Among University Students and Employees

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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