NCT06351787

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 2, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cortical activity

    Oxy-Hb and De-Oxy-Hb

    Baseline (T0)

  • Interoceptive awareness

    Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Baseline (T0)

  • Mindful awareness

    Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)

    Baseline (T0)

  • Pressure pain threshold and tolerance

    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 Outcomes (2)

  • Healthy emotionality

    Baseline (T0)

  • Well-being

    Baseline (T0)

Study Arms (2)

Body scan

EXPERIMENTAL

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.

Behavioral: Resting and movement-based focused awareness meditations

Yoga

EXPERIMENTAL

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.

Behavioral: Resting and movement-based focused awareness meditations

Interventions

Resting and movement-based focused awareness meditations

Body scanYoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults currently engaged in yoga

You may not qualify if:

  • History of any neurological disorder that could impair brain function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Nicholas Karayannis

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

October 31, 2022

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations