- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06351787
Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis
Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Adults: Correlates With Interoceptive Awareness, Healthy Emotionality, and Pain Perception
In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.
Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).
Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan->yoga intervention sequence compared to the yoga->body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Aim 1a, we will use self-report measures of interoception and awareness, using the Multidimensional Assessment of Interoceptive Awareness (MAIA) and the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF), and fNIRS to capture cortical activity during brief exposures to resting (Body scan) and movement-based (yoga) practices. We predict that self-reported interoception and awareness will moderately, and directly correlate with prefrontal cortical activity during the Body Scan and Yoga practices. In other words, we expect that higher levels of self-reported interoception and awareness will be positively associated with higher levels of prefrontal cortical activity for both awareness-focused practices.
In Aim 1b, we will use (i) the self-report measures (MAIA and FFMQ-SF) to identify a 'regulatory awareness' cluster and 'acceptance in action' cluster, and (ii) the quantitative sensory test of pressure pain tolerance. We will test the hypothesis that individuals categorized into the 'acceptance in action' cluster will demonstrate higher pressure pain threshold and tolerance compared to the 'regulatory awareness' cluster.
In Aim 2, we will use cortical activity levels captured using fNIRS during two awareness-based practices - Body Scan and Yoga. We expect that cortical activity will be higher during Yoga compared to Body Scan (Aim 2a). We further expect that individuals who initially receive the resting-based meditation and then progress to receive the active-based meditation (Body Scan->Yoga) will at a group level demonstrate higher levels of cortical activity in comparison to individuals who receive Yoga->Body Scan (Aim 2b).
In Aim 3, we will use self-report measures of interoception (MAIA) and self-report measures of healthy emotionality (Emotional Styles Questionnaire, ESQ) and psychological well-being (Scales of Psychological Well-Being, PWB). We predict that interoception will be moderately correlated with healthy emotionality and psychological well-being.
Our contribution will be significant because elucidating cognitive and affective processes of awareness-based practices will help inform who may more favorably respond to different awareness-based practices aimed at cultivating well-being. Our proposed research is innovative because it seeks to advance a sensorimotor and psychological mechanistic understanding of meditation practices that will elucidate the 'active ingredients' responsible for its therapeutic effect.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults currently engaged in yoga
Exclusion Criteria:
- History of any neurological disorder that could impair brain function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Body scan
Participants will follow an audio-guided meditation in the sitting posture, which provides systematic verbal cues to draw their attention to different body parts to cultivate non-judgmental awareness.
This will be performed in blocks of 2-minute increments, for up to 10 minutes, interspersed with 30-second periods of rest - where the participant will allow their mind to wander freely.
|
Resting and movement-based focused awareness meditations
|
|
Experimental: Yoga
Participants will follow a video-guided yoga session in the standing posture, which provides verbal and visual cues to draw their attention to their body and breath during upright yoga postures.
This practice occurs in 2-minute active intervals for up to 10 minutes, interspersed with 30-second rest to be consistent with the experimental block design.
|
Resting and movement-based focused awareness meditations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical activity
Time Frame: Baseline (T0)
|
Oxy-Hb and De-Oxy-Hb
|
Baseline (T0)
|
|
Interoceptive awareness
Time Frame: Baseline (T0)
|
Multidimensional Assessment of Interoceptive Awareness (MAIA)
|
Baseline (T0)
|
|
Mindful awareness
Time Frame: Baseline (T0)
|
Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
|
Baseline (T0)
|
|
Pressure pain threshold and tolerance
Time Frame: Baseline (T0)
|
Computerized pressure pain algometry applied over the ventral thenar eminence, 3 series of ascending stimulus intensities, applied as a slowly increasing ramp of 50 kPa/s.
Pain threshold is defined as the first perception or detection of pain, or a numeric rating of 2 on a scale of 0 to 10, where 0 = no sensation and 10 = worst imaginable pain.
Pain tolerance is defined as the point of maximum tolerable pain, a numeric pain rating of 8 on a scale of 0 to 10.
|
Baseline (T0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy emotionality
Time Frame: Baseline (T0)
|
Emotional Styles Questionnaire (ESQ)
|
Baseline (T0)
|
|
Well-being
Time Frame: Baseline (T0)
|
Scales of Psychological Well-Being (SPWB)
|
Baseline (T0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicholas Karayannis, Ohio University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-X-97
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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