Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-04-20
Study Completion Date
2018-08-02
Brief Summary
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Mindfulness meditation has been shown to reduce pain in experimental and clinical settings, and the neural mechanisms underlying this analgesia are distinct from that of placebo related beliefs in the utility of the meditation. Although previous studies have identified potential cortical and sub-cortical targets responsible for mediating these effects, the connectional relationships between them remains largely unexplored. The present study will use blood-oxygen-level dependent (BOLD) neuroimaging to assess functional connections supporting mindfulness meditation.
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Detailed Description
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Mindfulness meditation, significantly reduces pain in experimental and clinical settings. Although findings from this laboratory provide novel insights into some of the brain mechanisms supporting the modulation of pain by meditation , the specific analgesic mechanisms engaged during mindfulness meditation remain poorly characterized.
To date, there are no studies that have identified the neurofunctional connections supporting mindfulness meditation-based pain relief. Employing fMRI, the objective of this study will be to determine the neural systems of action supporting mindfulness-based pain relief. The study will determine if higher order brain regions are involved in mindfulness-based analgesia. The results from this aim will identify a neural marker(s) for meditation-related pain relief, a critical step in defining how meditation reduces pain.
To date, there are no studies that have identified the neurofunctional connections supporting mindfulness meditation-based pain relief. Employing fMRI, the objective of this study will be to determine the neural systems of action supporting mindfulness-based pain relief. The study will determine if higher order brain regions are involved in mindfulness-based analgesia. The results from this aim will identify a neural marker(s) for meditation-related pain relief, a critical step in defining how meditation reduces pain.
Conditions
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Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Healthy research participants, trained to psychophysically rate their experience in response to a range of thermal stimuli, will be randomly assigned to one of two experimental groups (mindfulness meditation n=20 or deep-breathing meditation n=20). After receiving four twenty-minute meditation training sessions, participants will return for a final session of thermal testing while lying in the MRI scanner. Participants will be exposed to 4 blocks of testing, using thermal stimuli cycled between painful (49°C) and non-painful (35°C) temperatures for 6 minutes. Blood oxygen-level dependent imaging will be used to map the functional connectivity of brain regions in response to the thermal fluctuations. In the first two blocks participants will lie quietly with eyes closed. After a 10 minute rest, subjects will begin meditating and the thermal testing will resume.
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Subjects will be randomly assigned to two groups by the research coordinator. Investigators, study staff and MRI technicians will be blind as to the participant's group assignment.
Study Groups
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Mindfulness Meditation Group
Research volunteers will participate in four sessions (20 min/session) of mindfulness training. Participants are taught that perceived sensory events are "momentary" and "fleeting", requiring no further evaluation. They will be asked to close their eyes, relax and focus on the flow of their breathing by "simply letting go" of discursive thoughts.
Group Type
EXPERIMENTAL
Mindfulness Training
Intervention Type
BEHAVIORAL
A well-validated brief mindfulness-based mental training regimen \[four sessions; 20 min/session\] will be used to teach patients to independently practice mindfulness meditation.
Book Listening Control
Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 4 session sequence is meant to match features of the experimental meditation sessions, including attention to the recording, room setting, social support, conditioning, and time elapsed during the sessions. We do not expect that this group will demonstrate significant blood oxygenation changes as a function of the intervention.
Group Type
ACTIVE_COMPARATOR
Book Listening Control
Intervention Type
BEHAVIORAL
Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.
Interventions
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Mindfulness Training
A well-validated brief mindfulness-based mental training regimen \[four sessions; 20 min/session\] will be used to teach patients to independently practice mindfulness meditation.
Intervention Type
BEHAVIORAL
Book Listening Control
Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.
Intervention Type
BEHAVIORAL
Other Intervention Names
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mental training
mental training
Eligibility Criteria
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Inclusion Criteria
* Normal volunteers between ages 18 and 65.
* Men and women of all races will be included
* Men and women of all races will be included
Exclusion Criteria
* Subjects with a history of psychiatric or neurological disorders.
* Subjects will be excluded if they report being claustrophobic.
* Subjects with a prior history of meditation training will be excluded.
* Subjects with ferrous metal or electronic devices (e g., pacemakers) implanted in there body will be excluded.
* Pregnant subjects will be excluded.
* Subjects that demonstrate no pain to noxious temperatures (\>49°C) or excessive responses to temperatures at or below 43°C will be excluded.
* Subjects will be excluded if they report being claustrophobic.
* Subjects with a prior history of meditation training will be excluded.
* Subjects with ferrous metal or electronic devices (e g., pacemakers) implanted in there body will be excluded.
* Pregnant subjects will be excluded.
* Subjects that demonstrate no pain to noxious temperatures (\>49°C) or excessive responses to temperatures at or below 43°C will be excluded.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
lead
Responsible Party
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Fadel Zeidan
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Fadel Zeidan, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB00040373
Identifier Type: -
Identifier Source: org_study_id
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