An interventional study of Mindfulness meditation and Positive reappraisal in Pain and Regulation, Self, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Basic science
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.
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Exclusion Criteria:
Behavioral: Mindfulness meditation
Behavioral: Positive reappraisal
Participants will be trained to use mindfulness meditation to reduce pain perception.
Participants will be trained to use positive reappraisal to reduce pain perception.
Psychophysical Assessment of Pain
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".
Time frame: throughout study completion, up to 2 hours
Assessment of Physiologic Measurements
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.
Time frame: throughout study completion, up to 2 hours
Freiburg Mindfulness Inventory (FMI) (Short Form)
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.
Time frame: throughout study completion, up to 2 hours
Ways of Coping Scale (WOCS-PR; Positive Reappraisal Subscale)
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.
Time frame: throughout study completion, up to 2 hours
State Anxiety Inventory (SAI)
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.
Time frame: throughout study completion, up to 2 hours
Pain Catastrophizing Scale (PCS)
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.
Time frame: throughout study completion, up to 2 hours
Positive and Negative Affective Scale (PANAS)
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.
Time frame: throughout study completion, up to 2 hours
Beck Depression Inventory (BDI)
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.
Time frame: throughout study completion, up to 2 hours
Perceived Stress Scale (PSS)
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.
Time frame: throughout study completion, up to 2 hours
VAS of Analgesia
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".
Time frame: throughout study completion, up to 2 hours
VAS of Political Affiliation
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.
Time frame: throughout study completion, up to 2 hours
VAS of Stress
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.
Time frame: throughout study completion, up to 2 hours
Valence Ratings for Images
: 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.
Time frame: throughout study completion, up to 2 hours
Plan to share: No
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Started Nov 2017 (actual). Primary completion is estimated for May 2019, 18 months after the start.
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This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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