- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471689
Multisensory Integration and Pain Perception
June 4, 2019 updated by: Wake Forest University Health Sciences
Pain is a predominant disruption of well-being among humans.
Feeling pain is a multimodal sensory experience where information is collected and processed from various senses such as sight and touch.
Because pain is complex, variable, and experienced differently by each individual, finding more accessible and practical treatments for pain are necessary.
Mindfulness meditation (MM) aims to reduce pain by directing focus to perceive thoughts through non-judgmental awareness.
Positive reappraisal (PR) is a possible cognitive pain treatment that focuses on changing the meaning of stressful or negative events into positive, benign, valuable, or beneficial.
When a stressful event, such as experiencing pain, is positively reappraised, the individual recognizes and engages with the feeling of stress produced by the event and intentionally looks for benefits that change the feeling from negative to positive.
The focus of this study is to examine the effect of different cognitive techniques on multimodal innocuous and noxious stimuli.
Visual and tactile noxious stimuli will be administered to determine how visual cue integrate to form and modulate the subjective experience of pain.
The study team postulates that mindfulness meditation and positive reappraisal will significantly reduce pain in response to multimodal stimulus (visual cue + noxious heat) when compared to a non-manipulation control condition.
These findings will be utilized to better understand the multidimensional mechanisms supporting nociception and the cognitive modulation of pain.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27109
- Wake Forest University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 23 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Native/fluent English speaker
- Ability to understand/willingness to sign consent form
Exclusion Criteria:
- Chronic pain
- Cardiac medications
- Diagnosis of mental illness or personality disorder
- Diagnosis of heart or lung conditions/hyper tension
- Taking psychiatric medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
|
Participants will be trained to use mindfulness meditation to reduce pain perception.
|
Active Comparator: Positive reappraisal
|
Participants will be trained to use positive reappraisal to reduce pain perception.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychophysical Assessment of Pain
Time Frame: throughout study completion, up to 2 hours
|
Pain intensity and unpleasantness ratings will be assessed with the Visual Analogue Scale (VAS).
If the participant states that he or she "is in no pain" or the pain "is not at all unpleasant," a rating of 0 will be recorded for pain intensity and unpleasantness, respectively.
The maximum rating of "10" will designate the "most intense pain imaginable/the most unpleasant pain imaginable".
|
throughout study completion, up to 2 hours
|
Assessment of Physiologic Measurements
Time Frame: throughout study completion, up to 2 hours
|
Participants may be fitted with electrocardiography (ECG) sensors and a respiratory belt that is placed around the participant's chest.
Subjects may also be fitted with sensors that measure electrodermal activity.
All physiological activity will be recorded at a rate of 1 kHz and will be processed with an integrated software system.
Respiratory rate will be calculated in breaths per minute.
ECG sensors will be placed on the lower right and left ribs of the participant.
Respiration belt will be attached to the upper chest, and two 6 mm Ag/AgCl skin conductance electrodes will be placed on the distal phalanges of the first and second fingers of the non-dominant hand.
Higher scores reflect more physiological arousal to pain stimuli.
|
throughout study completion, up to 2 hours
|
Freiburg Mindfulness Inventory (FMI) (Short Form)
Time Frame: throughout study completion, up to 2 hours
|
This 14-item form assesses self- attributed mindfulness.
The inventory is composed of 14 items that use a 1 to 4 Likert scale.
Obtaining a higher score represents higher mindfulness.
|
throughout study completion, up to 2 hours
|
Ways of Coping Scale (WOCS-PR; Positive Reappraisal Subscale)
Time Frame: throughout study completion, up to 2 hours
|
The 7-item form assesses levels of positive reappraisal.
The WOCS- Positive Reappraisal Subscale has a total of seven questions.
It uses a Likert scale ranging from 0 to 3 and asks the participant to think of a specific stressful situation.
High scores on the PR subscale represent frequent use by the individual of positive reappraisal for stressful events.
|
throughout study completion, up to 2 hours
|
State Anxiety Inventory (SAI)
Time Frame: throughout study completion, up to 2 hours
|
This 20-item scale is commonly used to measure state anxiety and has internal consistency, construct validity, and test-retest reliability.
A score between 20 and 80 is given, with higher scores representing higher levels of anxiety.
|
throughout study completion, up to 2 hours
|
Pain Catastrophizing Scale (PCS)
Time Frame: throughout study completion, up to 2 hours
|
This 13-item form assesses rumination, magnification, and helplessness, attributes used in the literature to define pain catastrophizing.
Each item is given a score from 0 to 4. The total scores range from 0 to 52, with higher ratings representing higher levels of catastrophic thinking.
|
throughout study completion, up to 2 hours
|
Positive and Negative Affective Scale (PANAS)
Time Frame: throughout study completion, up to 2 hours
|
This scale measures general affective states by assessing a subject's experience of 20 different emotions.
This scale is scored on a 5-point scale, with higher scores for the positive questions representing higher levels of positive affect, and higher scores for the negative questions representing higher levels of negative affect.
|
throughout study completion, up to 2 hours
|
Beck Depression Inventory (BDI)
Time Frame: throughout study completion, up to 2 hours
|
This scale is a 21-question multiple-choice self-report inventory for measuring the severity of depression, and it has internal consistency, construct validity, and test-retest reliability.
There is a total of 21 questions with a Likert scale ranging from 0 to 3. Higher scores represent higher levels of depression.
|
throughout study completion, up to 2 hours
|
Perceived Stress Scale (PSS)
Time Frame: throughout study completion, up to 2 hours
|
This is a psychological instrument for measuring participant's perception of stress.
It has internal consistency, construct validity, and test-retest reliability.
There is a total of 10 questions with higher scores denoting higher levels of perceived stress.
|
throughout study completion, up to 2 hours
|
VAS of Analgesia
Time Frame: throughout study completion, up to 2 hours
|
Participants will be asked to indicate, by using the visual analog scale, how much pain they will expect to experience.
If the participant states that he or she "will experience no pain" or the pain "will not be unpleasant," a rating of 0 will be recorded for pain intensity and unpleasantness, respectively.
The maximum rating of "10" will designate the "most intense pain imaginable/the most unpleasant pain imaginable".
|
throughout study completion, up to 2 hours
|
VAS of Political Affiliation
Time Frame: throughout study completion, up to 2 hours
|
Using the VAS, participants will indicate where in the political spectrum they identify.
Participants will be instructed that the right side of the VAS corresponds to conservatism while the left corresponds to liberalism.
Participants will move the sliding scale on the VAS to the location corresponding to their political affiliation.
|
throughout study completion, up to 2 hours
|
VAS of Stress
Time Frame: throughout study completion, up to 2 hours
|
Participants will indicate with the VAS how stressed, from a scale of 0-10, they are at the present moment.
A rating of 0 will be recorded for "no stress" while a rating of 10 will be recorded for "highest" stress possible.
|
throughout study completion, up to 2 hours
|
Valence Ratings for Images
Time Frame: throughout study completion, up to 2 hours
|
: Participants for phase one will rate the images based on the International Affective Picture System (IAPS) valence ratings.
The ratings will use a Likert scale ranging from 1 (low pleasantness) to 9 (high pleasantness).
After the participants look at the image for 2 seconds, they will be asked to rate level of pleasantness in less than 5 seconds based on the immediate feeling experienced while viewing the image.
|
throughout study completion, up to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christian Waugh, PhD, Wake Forest University
- Principal Investigator: Fadel Zeidan, PhD, Wake Forest University Health Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2017
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
March 12, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (Actual)
March 20, 2018
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 4, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00046662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Mindfulness meditation
-
Oregon Health and Science UniversityCompleted
-
University Hospital, AngersNot yet recruitingLateral Sclerosis Amyotrophy | Mindfulness Meditation
-
University of Illinois at Urbana-ChampaignNorthwestern University Feinberg School of Medicine; Southern Illinois University and other collaboratorsNot yet recruitingPain, Postoperative | Depression, Unipolar
-
Universiti Tunku Abdul RahmanRecruiting
-
Icahn School of Medicine at Mount SinaiSuspendedPain, Postoperative | Spine Surgery | MeditationUnited States
-
York UniversityCompletedChronic Pain | Depression, AnxietyCanada
-
Jordan University of Science and TechnologyCompletedChronic Kidney Diseases | Hemodialysis ComplicationJordan
-
Kaiser PermanenteCompletedDepression | Anxiety | Advanced CancerUnited States
-
University of Southern CaliforniaAbbott Medical Devices; California Foundation for Occupational TherapyCompleted
-
University of MichiganCompletedChronic Obstructive Pulmonary DiseaseUnited States