Use of Fitbits During Breathing Meditation

NCT05101343 | Completed Results

• 3 other identifiers: IRB21074P20GM103499-20P217A180094
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Change in Mindfulness

  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.

  Baseline and 2 weeks post-baseline

• 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.)

  Baseline and 2 weeks post-baseline

• Change in Well-being

  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.

  Baseline and 2 weeks post-baseline

• Change in Worry

  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.

  Baseline and 2 weeks post-baseline

• Change in Depression

  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.)

  Baseline and 2 weeks post-baseline

Secondary Outcomes (4)

• Change in Sleep Minutes

  Baseline and 2 weeks

• Change in Heart Rate

  Baseline and 2 weeks

• Change in Steps

  Baseline and 2 weeks

• Change in Physically Active Minutes

  Baseline and 2 weeks

Study Arms (2)

Control

NO INTERVENTION

Uses Fitbit, does not participate in breathing meditation.

Meditation

EXPERIMENTAL

Uses Fitbit and participates in brief, daily breathing meditation.

Behavioral: Breathing meditation

Interventions

Breathing meditation BEHAVIORAL

Daily, 5-minute breathing meditation for one week.

Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years.
• Has previously practiced meditation.

Sponsors & Collaborators

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

Study Sites (1)

Winthrop University

Rock Hill, South Carolina, 29733, United States

Location

Results Point of Contact

• Title: Compliance Coordinator
• Organization: Winthrop University

smithmr@winthrop.edu

8033232460

Study Officials

• Courtney Guenther

  Winthrop University - Rock Hill, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 1, 2021
• Study Start: March 1, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)