Occupational StressNCT05595785
Yoga Versus Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting
A study testing Physical-Based Yoga Practice and Mindfulness-Based Yoga Practice in people with Occupational Stress, run by Jeanmarie R. Burke, PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- What is being tested?
- Physical-Based Yoga Practice and Mindfulness-Based Yoga Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 1917to 22 Jan 1918
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age Limits: from 20 years to 65 years of age
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: The Effects of Yoga or Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting
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).
Read the 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).
- Conditions
- Occupational Stress
- Being tested
- Physical-Based Yoga Practice, Mindfulness-Based Yoga Practice
- Keywords
- Yoga, Mindfulness, Stress, Psychological
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical-Based Yoga PracticeBehavioural
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
Mindfulness-Based Yoga PracticeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-Based Yoga Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start23 Jan 1917
- Primary completion22 Jan 1918
- Study completion22 Jan 1918
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeanmarie R. Burke, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeanmarie R. Burke, PhD, Northeast College of Health Sciences
- Investigators
- Jeanmarie R Burke, PhD, Study director, Northeast College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595785
- Sponsor's protocol ID
- 17-01
- Status last verified
- Nov 2022
- First submitted
- 15 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing includes study protocol, statistical analysis plan, and informed consent form upon e-mail request to Central Contact
Publications
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.
PubMed 25031113Taylor 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.
PubMed 25346996Cohen 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.
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.
PubMed 12703651Park 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.
PubMed 23539467
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga or Yoga Plus Mindfulness on Perceived Stress and Mindful Attention Awareness in a Chiropractic College Setting
- ClinicalTrials.gov ID
- NCT05595785
- Acronym / sponsor ID
- 17-01
- Conditions
- Occupational Stress
- Keywords
- Yoga, Mindfulness, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Jeanmarie R. Burke, PhDUniversity, hospital or other
- Study start
- 23 Jan 1917 (actual)
- Primary completion
- 22 Jan 1918 (actual)
- Study completion
- 22 Jan 1918 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical-Based Yoga Practice | Experimental | Behavioral: Physical-Based Yoga PracticeParticipants 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. |
| Mindfulness-Based Yoga Practice | Experimental | Behavioral: Mindfulness-Based Yoga PracticeParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female
- Age Limits: from 20 years to 65 years of age
Key exclusion criteria (11 listed)
- Pregnancy
- Nursing
- Wearing a pacemaker
- Prescription medications except for birth control or ADD/ADHD medications
- Stroke within the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical-Based Yoga PracticePhysical-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 | Behavioural | Physical-Based Yoga Practice |
| Mindfulness-Based Yoga PracticeThe 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. | Behavioural | Mindfulness-Based Yoga Practice |
Primary outcome
Changes in 10-Item Perceived Stress Scale
Time frame: 4 weeks
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
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 25031113Lee 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.
- Background: PubMed 25346996Taylor 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.
- BackgroundCohen 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: PubMed 12703651Brown 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.
- Background: PubMed 23539467Park 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.
- Individual participant dataSharing planned: Yes. IPD sharing includes study protocol, statistical analysis plan, and informed consent form upon e-mail request to Central Contact
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanmarie R Burke, PhD study director
Northeast College of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Physical-Based Yoga Practice and Mindfulness-Based Yoga Practice in people with Occupational Stress, run by Jeanmarie R. Burke, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 10-Item Perceived Stress Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595785, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.