NCT05595785

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1917

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 1917

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 1918

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 1918

Completed
104.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

October 15, 2022

Last Update Submit

November 1, 2022

Conditions

Keywords

YogaMindfulnessStressPsychological

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 weeks

  • 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.

    4 weeks

Study Arms (2)

Physical-Based Yoga Practice

EXPERIMENTAL

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.

Behavioral: Physical-Based Yoga Practice

Mindfulness-Based Yoga Practice

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Yoga Practice

Interventions

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

Physical-Based Yoga Practice

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.

Mindfulness-Based Yoga Practice

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25031113BACKGROUND
  • 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.

    PMID: 25346996BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12703651BACKGROUND
  • 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.

    PMID: 23539467BACKGROUND

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Jeanmarie R Burke, PhD

    Northeast College of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean of Faculty and Research

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 27, 2022

Study Start

January 23, 1917

Primary Completion

January 22, 1918

Study Completion

January 22, 1918

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

IPD sharing includes study protocol, statistical analysis plan, and informed consent form upon e-mail request to Central Contact

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Until December 31, 2024
Access Criteria
e-mail Central Contact with request