Use of Fitbits During Breathing Meditation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05101343

Enrollment

Registered

2021-11-01

Start date

2021-03-01

Completion date

2021-10-06

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BEHAVIORALBreathing meditation

Daily, 5-minute breathing meditation for one week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.)
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 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 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.

Secondary

Measure	Time frame	Description
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 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 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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Uses Fitbit, does not participate in breathing meditation.	17
Meditation Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.	17
Total	34

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Meditation	Total	Control
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	17 Participants	34 Participants	17 Participants
Age, Continuous	31 years STANDARD_DEVIATION 13	34 years STANDARD_DEVIATION 14	34 years STANDARD_DEVIATION 14
Race/Ethnicity, Customized Asian	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Black or African American	6 Participants	7 Participants	1 Participants
Race/Ethnicity, Customized Hispanic/Latino/Spanish	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Multi-racial	2 Participants	4 Participants	2 Participants
Race/Ethnicity, Customized Prefer not to answer	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized White	8 Participants	18 Participants	10 Participants
Region of Enrollment United States	17 participants	34 participants	17 participants
Sex: Female, Male Female	12 Participants	26 Participants	14 Participants
Sex: Female, Male Male	5 Participants	8 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 17	0 / 17
other Total, other adverse events	0 / 17	0 / 17
serious Total, serious adverse events	0 / 17	0 / 17

Outcome results

Primary

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.)