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Yoga Versus Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting

Primary Purpose

Occupational Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical-Based Yoga Practice
Mindfulness-Based Yoga Practice
Sponsored by
Jeanmarie R. Burke, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Occupational Stress focused on measuring Yoga, Mindfulness, Stress, Psychological

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or Female
  • Age Limits: from 20 years to 65 years of age

Exclusion Criteria:

  • Pregnancy
  • Nursing
  • Wearing a pacemaker
  • Prescription medications except for birth control or ADD/ADHD medications
  • Stroke within the past three months
  • Heart attack within the past three months
  • Surgery within the past three months
  • Car accident with injuries in the past three months
  • Litigation of any type within the past three months or currently
  • Currently participating in yoga activities once per week
  • Currently participating in mindfulness activities once per week

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Physical-Based Yoga Practice

    Mindfulness-Based Yoga Practice

    Arm Description

    Participants attended two 50-minute class sessions per week during the four week intervention phase. The physical-based yoga practice was Bishnu Ghosh lineage hatha yoga as taught by Mary Jarvis. The yoga class sessions included the physical postures of yoga with an emphasis on alignment, holding postures, and breathing normally. Each yoga class session sequentially included the following physical postures of yoga: (1) standing in stillness; (2) pranayama deep breathing and warm up; (3) standing series- balance postures, wide leg postures; (4) transition from the standing postures to the floor postures with tree pose; (5) floor series - wind removing, sit up movements, cobra posture, kneeling postures; (6) cool down-stretching, spine twist, Kapalbhati breathing, and Savasana.

    Participants attended two 50-minute class sessions per week during the four week intervention phase. The mindfulness-based yoga practice included all elements of the physical-based yoga class sessions with the addition of mindfulness cues. The mindfulness cues included body scan, mindful movement, and yoga nidra. Beyond verbal physical cues on how to control breathing and perform precise body movements during the yoga postures, verbal mindfulness cues asked participants to focus on the sensations of their breathing and body awareness non judgmentally, e.g. Feel your breathe move in through your nose and fill your lungs from bottom to top. Feel your breath exit the nose and empty lungs from top to bottom. Keep your attention on your breath and your body.

    Outcomes

    Primary Outcome Measures

    Changes in 10-Item Perceived Stress Scale
    Perceived Stress Scale (PSS-10) is 10 item questionnaire that asks participants to rate their feelings and thoughts during the last month within the context of how often they felt or thought a certain way in different situations. The rating scale is 0 - never, 1 - almost never, 2 - sometimes 3 - fairly often 4 - very often. Classification system of stress levels included 0 to 13 as low stress, 14 to 26 as moderate stress and 27 to 40 as high stress.
    Changes in 15-Item Mindful Attention Awareness Scale
    The mindfulness domain was measured using the 15-item Mindful Attention Awareness Scale (MAAS). MAAS assesses an individual's dispositional mindfulness, which defines individual's awareness and attention during every day experiences, i.e. being present in the moment. The MAAS rates attention and awareness related to everyday experiences. MAAS numeric scale is 1- almost always, 2 - very frequently, 3 - somewhat frequently, 4, - somewhat infrequently, 5 - very infrequently, and 6 - almost never. The average numeric rating is the score on MAAS with higher mean values reflecting greater dispositional mindfulness.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 15, 2022
    Last Updated
    November 1, 2022
    Sponsor
    Jeanmarie R. Burke, PhD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05595785
    Brief Title
    Yoga Versus Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting
    Official Title
    The Effects of Yoga or Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 23, 1917 (Actual)
    Primary Completion Date
    January 22, 1918 (Actual)
    Study Completion Date
    January 22, 1918 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jeanmarie R. Burke, PhD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: The purpose of the study was to compare the effects of different types of yoga practices on mindfulness and stress levels reported by students, faculty, and staff at a health professional school. Including mindfulness cues (body scan, mindful movement, and yoga nidra) with Bishnu Gosh lineage hatha yoga as taught by Mary Jarvis may have additive therapeutic effects on mindfulness and stress. Methods: This was a quasi-experimental pre-post test design. Sixty-three individuals qualified for the study and were randomized in a 1:1 allocation ratio of matched pairs into either a physical-based yoga practice (Yoga Group, n = 31) or a mindfulness-based yoga practice (Yoga + Mindfulness Group, n = 32). Participants attended two 50-minute class sessions per week during the four-week intervention phase. The primary outcomes were the 10-item Perceived Stress Scale (PSS-10) and the 15-item Mindful Attention Awareness Scale (MAAS).
    Detailed Description
    Objective: The purpose of the study was to compare the effects of different types of yoga practices on mindfulness and stress levels reported by students, faculty, and staff at a health professional school. Including mindfulness cues (body scan, mindful movement, and yoga nidra) with Bishnu Gosh lineage hatha yoga as taught by Mary Jarvis may have additive therapeutic effects on mindfulness and stress. Methods: This was a quasi-experimental pre-post test design. Sixty-three individuals qualified for the study and were randomized in a 1:1 allocation ratio of matched pairs into either a physical-based yoga practice (Yoga Group, n = 31) or a mindfulness-based yoga practice (Yoga + Mindfulness Group, n = 32). Participants attended two 50-minute class sessions per week during the four-week intervention phase. A sample size of 30 participants per class was deemed appropriate based upon the assumption of normality and the central limit theorem underlying the mathematics of inferential statistics. The yoga class sessions included the physical postures of yoga with an emphasis on alignment, holding postures, and breathing normally. Throughout the yoga class session, the instructor demonstrated the performances of the physical postures. While participants were performing the physical postures, the instructor provided verbal alignment cues to the participants. As needed, the instructor also demonstrated postural modifications, which allowed all participants to perform all physical postures. Each class session sequentially included the following physical postures of yoga: (1) standing in stillness; (2) pranayama deep breathing and warm up; (3) standing series- balance postures, wide leg postures; (4) transition from the standing postures to the floor postures with tree pose; (5) floor series - wind removing, sit up movements, cobra posture, kneeling postures; (6) cool down-stretching, spine twist, Kapalbhati breathing, and Savasana. The Yoga + Mindfulness class sessions included all elements of the yoga class session described above with the addition of mindfulness cues. The mindfulness cues included body scan, mindful movement, and yoga nidra. Beyond verbal physical cues on how to control breathing and perform precise body movements during the yoga postures, verbal mindfulness cues asked participants to focus on the sensations of their breathing and body awareness non judgmentally, e.g. Feel your breathe move in through your nose and fill your lungs from bottom to top. Feel your breath exit the nose and empty lungs from top to bottom. Keep your attention on your breath and your body. In general, the instructor reminded the participants throughout the Yoga + Mindfulness class session to "feel the sensation of ..."or "keep your attention on ..."as the instructor provided the alignment cues. The primary outcomes were pre-post changes in the 10-item Perceived Stress Scale (PSS-10) and the 15-item Mindful Attention Awareness Scale (MAAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Occupational Stress
    Keywords
    Yoga, Mindfulness, Stress, Psychological

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical-Based Yoga Practice
    Arm Type
    Experimental
    Arm Description
    Participants attended two 50-minute class sessions per week during the four week intervention phase. The physical-based yoga practice was Bishnu Ghosh lineage hatha yoga as taught by Mary Jarvis. The yoga class sessions included the physical postures of yoga with an emphasis on alignment, holding postures, and breathing normally. Each yoga class session sequentially included the following physical postures of yoga: (1) standing in stillness; (2) pranayama deep breathing and warm up; (3) standing series- balance postures, wide leg postures; (4) transition from the standing postures to the floor postures with tree pose; (5) floor series - wind removing, sit up movements, cobra posture, kneeling postures; (6) cool down-stretching, spine twist, Kapalbhati breathing, and Savasana.
    Arm Title
    Mindfulness-Based Yoga Practice
    Arm Type
    Experimental
    Arm Description
    Participants attended two 50-minute class sessions per week during the four week intervention phase. The mindfulness-based yoga practice included all elements of the physical-based yoga class sessions with the addition of mindfulness cues. The mindfulness cues included body scan, mindful movement, and yoga nidra. Beyond verbal physical cues on how to control breathing and perform precise body movements during the yoga postures, verbal mindfulness cues asked participants to focus on the sensations of their breathing and body awareness non judgmentally, e.g. Feel your breathe move in through your nose and fill your lungs from bottom to top. Feel your breath exit the nose and empty lungs from top to bottom. Keep your attention on your breath and your body.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical-Based Yoga Practice
    Intervention Description
    Physical-based yoga classes emphasized Bishnu Ghosh lineage hatha yoga. The 50 minute yoga classes were twice per week for four weeks. The yoga instructor had certifications in both Bikram and Amrit yoga practices and training in Bishnu Ghosh lineage hatha yoga as taught by Mary Jarvis
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-Based Yoga Practice
    Intervention Description
    The mindfulness-based yoga classes included all elements of the physical-based yoga classes with the addition of mindfulness cues. The mindfulness cues included body scan, mindful movement, and yoga nidra. Certification of the instructor included the Integrative Amrit Method of Yoga Nidra that was inclusive of the use of mindfulness cues that coincided with the physical postures of yoga.
    Primary Outcome Measure Information:
    Title
    Changes in 10-Item Perceived Stress Scale
    Description
    Perceived Stress Scale (PSS-10) is 10 item questionnaire that asks participants to rate their feelings and thoughts during the last month within the context of how often they felt or thought a certain way in different situations. The rating scale is 0 - never, 1 - almost never, 2 - sometimes 3 - fairly often 4 - very often. Classification system of stress levels included 0 to 13 as low stress, 14 to 26 as moderate stress and 27 to 40 as high stress.
    Time Frame
    4 weeks
    Title
    Changes in 15-Item Mindful Attention Awareness Scale
    Description
    The mindfulness domain was measured using the 15-item Mindful Attention Awareness Scale (MAAS). MAAS assesses an individual's dispositional mindfulness, which defines individual's awareness and attention during every day experiences, i.e. being present in the moment. The MAAS rates attention and awareness related to everyday experiences. MAAS numeric scale is 1- almost always, 2 - very frequently, 3 - somewhat frequently, 4, - somewhat infrequently, 5 - very infrequently, and 6 - almost never. The average numeric rating is the score on MAAS with higher mean values reflecting greater dispositional mindfulness.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or Female Age Limits: from 20 years to 65 years of age Exclusion Criteria: Pregnancy Nursing Wearing a pacemaker Prescription medications except for birth control or ADD/ADHD medications Stroke within the past three months Heart attack within the past three months Surgery within the past three months Car accident with injuries in the past three months Litigation of any type within the past three months or currently Currently participating in yoga activities once per week Currently participating in mindfulness activities once per week
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeanmarie R Burke, PhD
    Organizational Affiliation
    Northeast College of Health Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD sharing includes study protocol, statistical analysis plan, and informed consent form upon e-mail request to Central Contact
    IPD Sharing Time Frame
    Until December 31, 2024
    IPD Sharing Access Criteria
    e-mail Central Contact with request
    Citations:
    PubMed Identifier
    25031113
    Citation
    Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18.
    Results Reference
    background
    PubMed Identifier
    25346996
    Citation
    Taylor JM. Psychometric analysis of the Ten-Item Perceived Stress Scale. Psychol Assess. 2015 Mar;27(1):90-101. doi: 10.1037/a0038100. Epub 2014 Oct 27.
    Results Reference
    background
    Citation
    Cohen S, Janicki-Deverts D. Who's stressed? Distributions of psychological stress in the United States in probability samples from 1983, 2006, and 2009. J Appl Soc Psychol. 2012;42:1320-34.
    Results Reference
    background
    PubMed Identifier
    12703651
    Citation
    Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
    Results Reference
    background
    PubMed Identifier
    23539467
    Citation
    Park T, Reilly-Spong M, Gross CR. Mindfulness: a systematic review of instruments to measure an emergent patient-reported outcome (PRO). Qual Life Res. 2013 Dec;22(10):2639-59. doi: 10.1007/s11136-013-0395-8. Epub 2013 Mar 29.
    Results Reference
    background

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    Yoga Versus Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting

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