NCT03414138

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

January 16, 2018

Last Update Submit

June 7, 2019

Conditions

Pain

Keywords

PainMindfulnessMeditationfMRI

Outcome Measures

Primary Outcomes (1)

  • Blood oxygenation level dependent (BOLD) signaling

    Changes in blood oxygenation levels to thermally noxious stimuli (49°C) will be assessed, and planned comparisons will be performed between subjects trained in mindfulness meditation and those trained in deep-breathing meditation.

    Up to 3 weeks

Secondary Outcomes (1)

  • Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training

    Up to 3 weeks

Other Outcomes (10)

  • Respiration Rate

    Up to 3 weeks

  • Heart Rate

    up to 3 weeks

  • State Anxiety Inventory (SAI)

    up to 3 weeks

  • +7 more other outcomes

Study Arms (2)

Mindfulness Meditation Group

EXPERIMENTAL

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.

Behavioral: Mindfulness Training

Book Listening Control

ACTIVE COMPARATOR

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.

Behavioral: Book Listening Control

Interventions

Mindfulness TrainingBEHAVIORAL

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.

Also known as: mental training
Mindfulness Meditation Group
Book Listening ControlBEHAVIORAL

Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.

Also known as: mental training
Book Listening Control

Eligibility Criteria

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

You may qualify if:

  • Normal volunteers between ages 18 and 65.
  • Men and women of all races will be included

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (64)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fadel Zeidan, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 29, 2018

Study Start

April 20, 2018

Primary Completion

August 2, 2018

Study Completion

August 2, 2018

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

US(1)