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Completed

NCT Number: NCT05101343

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop University

Rock Hill, South Carolina, 29733, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Breathing meditation

Behavioral

Daily, 5-minute breathing meditation for one week.

Primary outcomes

  1. Change in Mindfulness

    Time frame: 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.

  2. Change in Anxiety

    Time frame: 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.)

  3. Change in Well-being

    Time frame: 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.

  4. Change in Worry

    Time frame: 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.

  5. Change in Depression

    Time frame: 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 outcomes

  1. Change in Sleep Minutes

    Time frame: Baseline and 2 weeks

    Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement.

  2. Change in Heart Rate

    Time frame: 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)

  3. Change in Steps

    Time frame: 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)

  4. Change in Physically Active Minutes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Winthrop University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
Jul 8, 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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