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Clinical Trials/NCT03856892
NCT03856892CompletedNot Applicable

Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice

Emory University2 sites in 1 country97 target enrollmentStarted: January 11, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
97
Locations
2
Primary Endpoint
Change in Heart Rate Variability (HRV) Between Study Arms

Study Overview

Brief Summary

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress, biochemical immunity and longevity markers, and validated psychological measures that relate to mental health.

Detailed Description

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress markers across the sympathetic-adreno-medullar (SAM) axis, biochemical immunity and longevity markers, and validated psychological measures as related to mental health. The study couples emic perspectives from the traditional yoga knowledge base, both textual and practice, with empirical measures from science as an opportunity to bridge these worlds as a first known study of hatha yoga to be tackled by the means and methods of biocultural anthropology. It therefore highlights the importance of context and detail in terms of assessing human behavioral practices, where accuracy in terms of definitions, technique detail, and original purported intentions and outcomes are addressed as relevant when measuring and explaining empirical outcomes under modern research mixed methods.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Novice to breath-based yoga practice
  • Multicultural international participant base
  • Fluent in English comprehension and reading
  • In general good health
  • Have a smartphone or similar device in order to receive surveys on a dedicated app

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Heart Rate Variability (HRV) Between Study Arms

Time Frame: Baseline, up to 6 months

Heart rate variability (HRV) is measured by electrocardiogram.

Secondary Outcomes

  • Change in Reactive Oxygen Species (ROS) Levels Between Study Arms(Baseline, up to 6 months)
  • Change in Skin Conductance Level (SCL) Between Study Arms(Baseline, up to 6 months)
  • Change in Skin Conductance Response Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Upper Abdominal Muscle Tension Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Self-assessment Questions Covering "how do you feel" score(Baseline, up to 6 months)
  • Change in Skin Conductance Response Between Study Arms(Baseline, up to 6 months)
  • Change in Reactive Oxygen Species (ROS) Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in levels of antioxidant enzyme Glutathione (GSH) Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Levels of Circulating Tumor-Necrosis Factor-alpha (TNF-α) Between Study Arms(Baseline, up to 6 months)
  • Change in Skin conductance level (SCL) Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Levels of Circulating IL-6 Between Study Arms(Baseline, up to 6 months)
  • Change in levels of circulating IL-6 Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Perceived Stress Reactivity Scale (PSRS) Score(Baseline, up to 6 months)
  • Change in Positive and Negative Affect Scale (PANAS) Score(Baseline, up to 6 months)
  • Change in Profile of Mood States (POMS) Score(Baseline, up to 6 months)
  • Change in Mindful Attention Awareness Scale (MAAS) Score(Baseline, up to 6 months)
  • Change in Heart Rate Variability (HRV) Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Total Antioxidant Status (TAS) Between Study Arms(Baseline, up to 6 months)
  • Change in Difficulties in Emotion Regulation Scale (DERS) Score(Baseline, up to 6 months)
  • Change in Depression Anxiety and Stress Scale (DASS) Score(Baseline, up to 6 months)
  • Change in Beck Anxiety Inventory (BAI-II) Score(Baseline, up to 6 months)
  • Change in Coping Self-efficacy Scale (CSES) Score(Baseline, up to 6 months)
  • Change in Self-Compassion Scale - Short Form (SCS-SF) Score(Baseline, up to 6 months)
  • Change in Spiritual Meaning Scale (SMS) Score(Baseline, up to 6 months)
  • Change in Total Antioxidant Status (TAS) Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Levels of Antioxidant Enzyme Glutathione (GSH) Between Study Arms(Baseline, up to 6 months)
  • Change in Penn State Worry Questionnaire (PSWQ) Score(Baseline, up to 6 months)
  • Changes in Multidimensional Assessment of Interoceptive Awareness (MAIA) 8-Subscale Scores(Baseline, up to 6 months)
  • Change in levels of circulating TNF-α Between High and Low Participation Level(Baseline, up to 6 months)
  • Change in Upper Abdominal Muscle Tension Between Study Arms(Baseline, up to 6 months)
  • Change in Compassion Scale (CS) Score(Baseline, up to 6 months)
  • Change in Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) Score(Baseline, up to 6 months)
  • Change in Gratitude Questionnaire - Six Item Form (GQ-6) Score(Baseline, up to 6 months)
  • Change in Perceived Stress Scale (PSS) Score(Baseline, up to 6 months)
  • Change in Beck Depression Inventory (BDI-II) Score(Baseline, up to 6 months)
  • Change in Heartland Forgiveness Scale Score(Baseline, up to 6 months)
  • Change in Five Facet Mindfulness Questionnaire (FFMQ) Score(Baseline, up to 6 months)
  • Change in Telomere Length (TL)(Baseline, up to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carol Worthman

Professor of Anthropology

Emory University

Study Sites (2)

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