Use of Fitbits During Breathing Meditation

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Breathing meditation

• Registration Number: NCT05101343
• Lead Sponsor: Winthrop University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-09-15
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Results First Submitted: 2022-10-05
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Results First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation	Breathing meditation	Uses Fitbit and participates in brief, daily breathing meditation.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety	Baseline and 2 weeks post-baseline	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.)
Change in Well-being	Baseline and 2 weeks post-baseline	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.
Change in Mindfulness	Baseline and 2 weeks post-baseline	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.
Change in Worry	Baseline and 2 weeks post-baseline	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.
Change in Depression	Baseline and 2 weeks post-baseline	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.)

Secondary Outcome Measures

Name	Time	Method
Change in Sleep Minutes	Baseline and 2 weeks	Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement.
Change in Steps	Baseline and 2 weeks	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)
Change in Heart Rate	Baseline and 2 weeks	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)
Change in Physically Active Minutes	Baseline and 2 weeks	Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement.

Trial Locations

Locations (1)

Winthrop University; 🇺🇸 Rock Hill, South Carolina, United States