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The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.

Primary Purpose

Anxiety, Satisfaction With Life, Loneliness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Care Program through Heartfulness
Sponsored by
Heartfulness Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study. Exclusion Criteria: Non-English speaking high school students and staff and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.

Sites / Locations

  • Ranjani B Iyer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heartfulness Group

Control Group

Arm Description

Participants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and loneliness scale.

The control group had no change in their daily routines.

Outcomes

Primary Outcome Measures

Assess the current level of Anxiety
To assess the current level of anxiety in high school students and staff through GAD Scale.
Changes level of Anxiety
To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.
Assess the current level of Satisfaction with Life
To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.
Changes level of Satisfaction with Life
To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.
Assess the current level of Loneliness
To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.
Changes in Loneliness levels
To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
May 16, 2023
Sponsor
Heartfulness Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05874232
Brief Title
The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Official Title
The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
July 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heartfulness Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.
Detailed Description
The specific aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Satisfaction With Life, Loneliness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heartfulness Group
Arm Type
Experimental
Arm Description
Participants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and loneliness scale.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group had no change in their daily routines.
Intervention Type
Behavioral
Intervention Name(s)
Self-Care Program through Heartfulness
Intervention Description
A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a weekly webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.
Primary Outcome Measure Information:
Title
Assess the current level of Anxiety
Description
To assess the current level of anxiety in high school students and staff through GAD Scale.
Time Frame
Week 0
Title
Changes level of Anxiety
Description
To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.
Time Frame
Week 4 and Week 8
Title
Assess the current level of Satisfaction with Life
Description
To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.
Time Frame
Week 0
Title
Changes level of Satisfaction with Life
Description
To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.
Time Frame
Week 4 and Week 8
Title
Assess the current level of Loneliness
Description
To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.
Time Frame
Week 0
Title
Changes in Loneliness levels
Description
To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.
Time Frame
Week 4 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study. Exclusion Criteria: Non-English speaking high school students and staff and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.
Facility Information:
Facility Name
Ranjani B Iyer
City
Novi
State/Province
Michigan
ZIP/Postal Code
48375
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.
IPD Sharing Time Frame
Starting six months after publication
IPD Sharing Access Criteria
Access criteria IPD and any additional supporting information will be shared with the researchers furthering research in stress management and emotional wellness tools.

Learn more about this trial

The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.

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