- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05621694
Exploring Oxytocin Response to Meditative Movement
September 8, 2023 updated by: Arizona State University
This pilot study is designed to test effects of a single session of meditative movement (Tai Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels.
Study Overview
Detailed Description
Endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (BP), suggesting that finding ways to increase oxytocin even in the absence of social connection, may be beneficial.
Meditative movement emphasizing breath, meditative state and flow-inducing movements holds potential for reducing BP, improving mood and releasing oxytocin.
In a single-group pilot study we exposed 21 OAs with mild-moderate hypertension to a 50-minute "Tai Chi Easy (TCE)" (simplified Tai Chi/Qigong) session, collecting BP, saliva samples for oxytocin, and psychosocial measures (connection, mood) pre/post intervention.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University Downtown Campus
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Phoenix, Arizona, United States, 85005
- Arizona State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
51 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 55-80 --BP above 120/80 -
Exclusion Criteria:
- having a neurologic disorder such as Parkinson's, seizure disorder, multiple sclerosis, Alzheimer's disease
- answered "yes" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q is a seven-question assessment that determines one's readiness, safety and ability to engage in physical activity and is safely validated for older adults
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Qigong/Tai Chi Intervention
Tai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy"
|
A meditative movement practice that includes simple qigong movement/breath practices and single, repeated tai chi movements taught to generate a meditative state and flow
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Blood Pressure
Time Frame: Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention
|
Using blood pressure cuff, conducting two consecutive readings of systolic and diastolic
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Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Profile of Mood States; Short Form
Time Frame: Change from pre-intervention mood to immediately post-50-minute intervention point
|
Using only subscales for depression and tension, 14 items with response format 0-4, reporting mean of responses, range 0-4 with higher scores indicating higher levels of depression and tension.
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Change from pre-intervention mood to immediately post-50-minute intervention point
|
|
Change in perception of Connection (this is not a published scale, no formal name, created for this study)
Time Frame: Change from pre-intervention to immediately after the 50-minute intervention
|
Two items assessing perception of connection with others and connection with self, score range
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Change from pre-intervention to immediately after the 50-minute intervention
|
|
Change in Salivary Oxytocin
Time Frame: Change from pre-intervention to immediately after the 50-minute intervention
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Saliva collection pre and post-intervention
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Change from pre-intervention to immediately after the 50-minute intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The De Jong Gierveld Loneliness Scale
Time Frame: pre-intervention only
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6 items each scored either 0 (not at all) 1 (somewhat lonely) or 2 (more lonely), score is computed as a mean across items, range 0-6 with higher scores indicating more loneliness
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pre-intervention only
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Flow State Scale
Time Frame: immediately after the intervention
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Used to assess perceptions of the experience of flow while performing the Tai Chi Easy intervention.
36 items, Score range 36-80, high scores indicate greater sense of flow.
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immediately after the intervention
|
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Meditative Movement Inventory
Time Frame: immediately after the intervention
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Scales that assess the experience of meditative state and breath focus during intervention, 11 items, score range 11-66 (or reported as a mean of the scores on the scale, then 1-6 range), with higher numbers indicating less breath focus and meditative state.
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immediately after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linda K Larkey, PhD, Arizona State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2017
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
November 15, 2022
First Posted (Actual)
November 18, 2022
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Will publish with indication that IPD data that is de-identified is available upon request.
IPD Sharing Time Frame
Data will be available after study results are published and for 5 years after.
IPD Sharing Access Criteria
Requests from active researchers with current positions in research institutions will be reviewed by PI
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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