Use of Fitbits During Breathing Meditation

This study will examine short breathing meditations paired with Fitbit technology in order to assess mindfulness and track physical activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Breathing meditation

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Rock Hill, South Carolina, United States, 29733
      • Winthrop University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Older than 18 years.
• Currently a student, faculty, or staff member at university where research is being completed.
• Able to wear a Fitbit close to 24 hours a day for two weeks.

Exclusion Criteria:

• Younger than 18 years.
• Has previously practiced meditation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Uses Fitbit, does not participate in breathing meditation.
Experimental: Meditation; Uses Fitbit and participates in brief, daily breathing meditation.	Behavioral: Breathing meditation; Daily, 5-minute breathing meditation for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mindfulness	Mindful Attention Awareness Scale (MAAS.) The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness,namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. The survey consists of 15 questions using a Likert scale. Responses range from 1 (Almost Always) to 6 (Almost Never.)The scale is scored by computing a mean of the 15 items on the questionnaire. Score ranges of 15 (low) to 90 (high.) A higher score indicates a higher level of dispositional mindfulness.	Baseline and 2 weeks post-baseline
Change in Anxiety	Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)	Baseline and 2 weeks post-baseline
Change in Well-being	Mental Health Continuum Short Form (MHC-SF.) This questionnaire measures emotional, psychological, and social well-being. It consists of 14 questions scored on a Likert scale ranging from 0-5. Items 1-3 indicate emotional well-being (range 0-15). Items 4-8 indicate social well-being (0-25). Items 9-14 indicate psychological well-being (0-30). Total well-being score as reported here was calculated by adding the three sub-scores together (range 0-70). Higher scores indicate higher well-being for subscales and total well-being.	Baseline and 2 weeks post-baseline
Change in Worry	UMC (University Medical Centre) Penn State Worry Questionnaire. This is a 16 item questionnaire. Scale ranges from 0 (Not Typical at All) to 4 (Very Typical.) A higher score indicates a higher propensity for worry.	Baseline and 2 weeks post-baseline
Change in Depression	Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)	Baseline and 2 weeks post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Minutes	Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement.	Baseline and 2 weeks
Change in Heart Rate	Changes in heart rate in beats per minute as measured by Fitbit (average observed heart rate during Week 2 minus the average heart rate observed during Week 1)	Baseline and 2 weeks
Change in Steps	Change in number of steps taken as measured by Fitbit (average number of steps taken during Week 2 minus the average number of steps taken during Week 1)	Baseline and 2 weeks
Change in Physically Active Minutes	Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement.	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Winthrop University
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Courtney Guenther, Winthrop University - Rock Hill, SC

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): October 6, 2021

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB21074; P20GM103499-20 (U.S. NIH Grant/Contract); P217A180094 (Other Grant/Funding Number: Winthrop McNair Scholars Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No