- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720297
Buckeye Pause Bundle
The Buckeye Pause Bundle: Augmenting State of Mind and Body as the Ultimate Personal Protective Equipment (PPE)
Study Overview
Status
Intervention / Treatment
Detailed Description
Exposure to acute and chronic stress physical and emotional stress within the workforce increases risk to various negative health outcomes including burnout, suicidal ideation, suppressed immunity, obesity, substance abuse, and heart disease. Chronic stress inhibits productivity while also increasing the chance for musculoskeletal strains, on-the-job injuries, and mental and emotional dysregulation. Moreover, employees experiencing high physical, cognitive and/or emotional stress are on sick leave more often than those who report lower amounts of stress. Employers with staff who work in high-stress environments are placed under severe financial burden, as the estimated annual indirect and direct costs associated with chronic stress is approximately $300 billion dollars. As such, finding ways to mitigate and protect workers from high levels of chronic physical and emotional stress should be an essential safety focus for Ohio companies and institutions.
The effects of physical and emotional stress can be cumulative and result in cascading effects on multiple body systems through a concept known as "allostatic load." Allostatic load refers to the consequential impacts of exposure to large fluctuations and/or significant neural and neuroendocrine responses that can arise from repeated or persistently high stress loads. Stress affects the regulation of various allostatic systems with activation of the sympathetic-adrenal-medullary pathway and the hypothalamic-pituitary-adrenal axis. The release of the various neurotransmitters and hormones involved in these systems, including pro-inflammatory molecules, can change the function of the peripheral and central nervous systems leading to various symptoms like irritability, nervousness, feeling overwhelmed, having difficulty concentrating or remembering. When stress levels exceed an individual's ability to manage and cope, allostatic overload can occur, which is a physiological state in which the stress response system can become activated easier and more frequently as well as persist for longer periods of time before shutting off.
Current best practice evidence-based solutions to counterbalance allostatic overload include mind-body resilience-building interventions such as mindfulness, meditation, yoga, strength training and aerobic activity. The foundational premise behind mind-body resilience-building is that the body systems, particularly the nervous, cardiovascular, and musculoskeletal systems, can be trained to resist allostatic overload through specific physical, cognitive, and behavioral practices.
Mindfulness in Motion (MIM), an established well-being program, is a mindfulness-based intervention that provides a modified, less time intensive method for busy adults to experience the benefits of mindfulness. The program offers evidence-based mindful awareness principles, community support through group discussions and emphasizes the use of gentle yoga stretches and relaxing music during all practices. Delivered in a group format for one hour per week over eight weeks, a companion website and smartphone app that will be developed will provide audio and video practices to support individual practice that complement the in-person programming.
Wearable devices that can monitor allostatic load, including heart rate, heart rate variability, physical activity level, breathing patterns, and sleep, throughout the day can provide a personalized way of increasing self-awareness of cumulative stress loads and increased risk for allostatic overload. Strategically leveraging technologies to provide biofeedback to workers about stress states can help establish new opportunities to integrate prompting systems to encourage and justify taking pauses while on duty to carry out mind-body resilience-building and recovery exercises. According to previous findings, the Oura ring provides accurate sleep data with preliminary evidence supporting the accuracy of sleep physiology (i.e., heart rate variability) and can be paired with a messaging system and built for withstanding the expected wear-and-tear of highly manual tasks and hazardous environments, making them a good choice for health care settings where infection control requires a lot of hand washing, potential chemical exposures, and recurrent physical/manual activities.
Lastly, participants from our previous studies have identified that consistent practice of mindfulness can be difficult while on duty in acute care settings due to difficulty finding a quiet, appropriate, and private environment. In collaboration with hospital leadership and operational teams, private spaces for this project, named Buckeye Paws Respite Spaces, will be implemented for participants to complete their daily practices.
The primary purpose of this study is to assess the feasibility, effectiveness, and utility of a Buckeye Pause Bundle as an add-on to the Mindfulness in Motion Program. The Bundle will include:
- An Oura Ring to assess physiological changes in metrics such as sleep, heart rate variability, and activity using wearable sensors during program participation.
- Access to Buckeye Pause Respite Spaces for healthcare professionals to practice mindfulness and meditation during their workday at the OSU Wexner Medical Center.
Objectives of this study include:
- Assess changes in survey measures from pre- to post-program (pre- and post-program survey items)
- Assess the experience of program participants who use the website or app to self-administer program components delivered outside of the in-person class sessions. This is assessed through the program evaluation of the website or app that participants fill out.
- Assess compliance in completing each portion of the program website or app
- Assess experiences with program modules through review of the reflective question per module to see if they enhanced the participant experience (module questions)
- Assess differences between participant groups to support enhancement of the program website or app for each group.
- Assess experiences with other program components (program evaluation questions)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Columbus, Ohio, United States, 43210
- Ohio State University Wexner Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Actively employed as a healthcare professional/healthcare employee at one of four associated hospitals in Ohio
- Ability to read and speak English.
- Access to a personal smartphone or computer and willingness to download study applications.
- WiFi access in order to enable access to study related materials, i.e. questionnaires, study instructions, etc.
Exclusion Criteria:
1. Previously participation/completion of the Mindfulness in Motion program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Augmented Mindfulness-based Intervention
Mindfulness in Motion (8-week mindfulness-based intervention) that includes access to companion website or smartphone app for supplementary information to support individual practice outside of in-person weekly sessions plus use of Oura ring wearable plus access to worksite respite spaces
|
8-week Mindfulness in Motion intervention that includes supplementary content through the Mindfulness in Motion website or smartphone app (to support individual practice outside of the in-person intervention) plus the use of an Oura ring to receive physiologic information, prompts, and text messages plus access to worksite respite spaces.
Other Names:
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|
Active Comparator: Mindfulness-based intervention
Mindfulness in Motion (8-week mindfulness-based intervention) that includes access to companion website for supplementary information to support individual practice outside of in-person weekly sessions.
|
8-week Mindfulness in Motion program that includes access to website for supplementary information to support individual practice outside of in-person weekly sessions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale-10 (PSS-10)baseline
Time Frame: baseline and on completion of the 8-week intervention
|
Perceived Stress Scale-10 (PSS-10).
A 10-item self-report measure of perceived stress.
It is a measure of the degree to which situations in one's life are appraised as stressful over the past month.
The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often).
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
baseline and on completion of the 8-week intervention
|
|
Maslach Burnout Inventory-Health Services Survey (MBI-HSS)
Time Frame: baseline and on completion of the 8-week intervention
|
The MBI-HSS is a self-report assessment of perceptions of burnout specific to healthcare providers.
The 22-items describe job-related feelings that healthcare providers may experience in the workplace and encompasses three sub scales of emotional exhaustion, depersonalization, and personal accomplishment.
The Likert scale responses include 0 (never), 1 (a few times a year or less), 2 (once a month or less), 3 (a few times a month), 4 (once a week), 5 (a few times a week), and 6 (every day).
Each sub scale can have a total score of low, moderate, or high with emotional exhaustion scores: low 0-18, moderate 19-26, high 27 or greater; depersonalization scores: low 0-5, moderate 6-9, high 10 or greater; and personal accomplishment scores: low greater than 40, moderate 34-39, and high 0-33.
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baseline and on completion of the 8-week intervention
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Connor-Davidson Resilience Scale-10 (CD-RISC-10)
Time Frame: baseline and on completion of the 8-week intervention
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The Connor-Davidson Resilience Scale-10 (CD-RISC-10) is a 10-item self-report assessment of a person's ability to bounce back after adversity.
A 5-point Likert Scale for each statement ranges from 0 (Not True at All), 1 (Rarely True), 2 (Sometimes True), 3 (Often True), 4 (True Nearly All of the Time).
A respondent's total score can range from 0 to 40 with higher scores indicating higher resilience.
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baseline and on completion of the 8-week intervention
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Utrecht Work Engagement Scale-9 (UWES-9)
Time Frame: baseline and on completion of the 8-week intervention
|
The Utrecht Work Engagement Scale-9 (UWES-9) is a 9-item assessment of attitudes towards one's job.
The UWES-9 measures three primary factors including dedication, vigor, and absorption.
Each subscale score, answered on a seven-point Likert scale ranging from 0 (Never), 1 (Almost never, a few times a year or less), 2 (Rarely, once a month or less), 3 (Sometimes, a few times a month), 4 (Often, once a week), 5 (Very often, a few times a week), and 6 (Always, every day), has a range of 0 to 18. Higher scores for each sub scale indicate higher dedication, vigor, and absorption with work.
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baseline and on completion of the 8-week intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryanna Klatt, PhD, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022B0260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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