An interventional study of Guided Meditation in Head Injury Trauma, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 13 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Basic science
The purpose of this research is to explore potential methods of rehabilitating changes observed from repetitive head impacts. Participation in this study will involve functional magnetic resonance (fMRI) imaging, aerobic testing, heart rate variability (HRV) wrist monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out survey information concerning subjective well-being.
COLLEGE ATHLETES:
At each study visit, participants will undergo an fMRI-cerebrovascular reactivity (CVR) challenge scanning session as well as an aerobic exercise test on a stationary bike. During the CVR-fMRI scan, the participant will wear a mask that will deliver a blend of oxygen and nitrogen at varying amounts while lying in an MRI scanner. During the aerobic stationary bike assessment, the participant will pedal at a steady state against applied resistance for 10 minutes while wearing an ECG heart rate monitor to observe heart rate. A Biostrap heart rate variability (HRV) wrist monitor will be provided which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. After the conclusion of the sport's season, there will be a follow up scanning session. After the post-season scan, the participant will participate in a breath work meditation intervention over the following two months, twice a week for a 30 minute meditation session.
HIGH SCHOOL ATHLETES:
Participants will be given a Biostrap HRV monitor which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. High school athletes will be randomized into one of two study groups, the control group or the intervention group. The intervention group will receive guided meditation over 2 months (twice a week for 30 mins each session), and will ride a stationary bike at 3 time points. The control group will proceed about their lives normally.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 137 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
The Intervention group will receive 30-minute sessions of guided meditation. During meditation, they will lie down with their backs and torsos elevated by a mat/soft blocks. They will undergo guided breath work.
Behavioral: Guided Meditation
The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.
Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Neuroimaging
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Time frame: Baseline
Neuroimaging
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Time frame: 7 months
Heart Rate Variability (HRV)
An aerobic bike test will be used to examine HRV. Upon conclusion of the exercise challenge, HRV will be measured using standard methods, During the warm up and test, they will be wearing apical ECG leads to record heart rate activity.
Time frame: Baseline
Heart Rate Variability (HRV)
An aerobic bike test will be used to examine HRV. Upon conclusion of the exercise challenge, HRV will be measured using standard methods, During the warm up and test, they will be wearing a Biostrap ECG heart rate monitor to record heart rate activity.
Time frame: 7 months
Measurement of Sleep
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
Time frame: Baseline
Measurement of Sleep
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
Time frame: 7 months
The Fear of Pain Questionnaire-III (FPQ-III)
A 30-item questionnaire used to assess the fear of pain, including Severe Pain, Minor Pain, and Medical Pain subscales. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extreme), and the total score ranges from 30 to 150.
Time frame: Baseline
The Fear of Pain Questionnaire-III (FPQ-III)
A 30-item questionnaire used to assess the fear of pain, including Severe Pain, Minor Pain, and Medical Pain subscales. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extreme), and the total score ranges from 30 to 150.
Time frame: 7 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences