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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04589520
Other study ID # 2019/07/11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2019
Est. completion date October 31, 2019

Study information

Verified date October 2020
Source Heartfulness Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older. Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older? Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date October 31, 2019
Est. primary completion date October 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age. Exclusion Criteria: - Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HeartBot App
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner.

Locations

Country Name City State
United States Ranjani B Iyer Novi Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ranjani Iyer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Stress Levels Participant stress levels were measured using the Perceived Stress Scale (PSS). This 10-item scale measures the degree to which a situation in someone's life is considered stressful . 21 days for 30 minutes every day based on a 21-day calendar
Secondary Change in Emotional Wellbeing The emotional wellness of the participants was measured using the EPOCH measure of adolescent wellbeing. This is a 20-item scale used to measure five different positive characteristics: Engagement, Perseverance, Optimism, Connectedness, and Happiness. 21 days for 30 minutes every day based on a 21-day calendar
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