Use of Fitbits During Breathing Meditation

Healthy Clinical Trial

Official title:

Use of Fitbits During Breathing Meditation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101343
• Other study ID #: IRB21074
• Secondary ID: P20GM103499-20P2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 6, 2021

Study information

• Verified date: October 2021
• Source: Winthrop University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Respiratory Aspiration

Intervention

Behavioral:
• Breathing meditation
Daily, 5-minute breathing meditation for one week.

Locations

Country	Name	City	State
United States	Winthrop University	Rock Hill	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Winthrop University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mindfulness	Mindful Attention Awareness Scale (MAAS)	Baseline and 2 weeks post
Primary	Change in Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS)	Baseline and 2 weeks post
Primary	Change in Well-being	Mental Health Continuum Short Form (MHC-SF)	Baseline and 2 weeks post
Primary	Change in Worry	UMC Penn State Worry Questionnaire	Baseline and 2 weeks post
Primary	Change in Program Feasibility and Acceptability	Surveys created by researcher	Baseline and 2 weeks post
Secondary	Change in Sleep	Duration and type of sleep measured using Fitbit	Throughout 2 week study
Secondary	Change in Heart Rate	Fitbit	Throughout 2 week study
Secondary	Change in Steps	Fitbit	Throughout 2 week study
Secondary	Change in Calories	Fitbit	Throughout 2 week study
Secondary	Change in Exercise	Types of exercise and duration	Throughout 2 week study