Use of Fitbits During Breathing Meditation

• Sponsor: Winthrop University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05101343
• Collaborator: National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Breathing meditation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use of Fitbits During Breathing Meditation
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Oct 6, 2021
• Actual Study Completion Date: Oct 6, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Mindfulness [Baseline and 2 weeks post]

   Mindful Attention Awareness Scale (MAAS)

2. Change in Anxiety and Depression [Baseline and 2 weeks post]

   Hospital Anxiety and Depression Scale (HADS)

3. Change in Well-being [Baseline and 2 weeks post]

   Mental Health Continuum Short Form (MHC-SF)

4. Change in Worry [Baseline and 2 weeks post]

   UMC Penn State Worry Questionnaire

5. Change in Program Feasibility and Acceptability [Baseline and 2 weeks post]

   Surveys created by researcher

Secondary Outcome Measures

1. Change in Sleep [Throughout 2 week study]

   Duration and type of sleep measured using Fitbit

2. Change in Heart Rate [Throughout 2 week study]

   Fitbit

3. Change in Steps [Throughout 2 week study]

   Fitbit

4. Change in Calories [Throughout 2 week study]

   Fitbit

5. Change in Exercise [Throughout 2 week study]

   Types of exercise and duration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Winthrop University	Rock Hill	South Carolina	United States	29733

Sponsors and Collaborators

• Winthrop University
• National Institute of General Medical Sciences (NIGMS)

Investigators

• Principal Investigator: Courtney Guenther, Winthrop University - Rock Hill, SC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Winthrop University
• ClinicalTrials.gov Identifier: NCT05101343
• Other Study ID Numbers: IRB21074; P20GM103499-20; P217A180094
• First Posted: Nov 1, 2021
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 1, 2021