PainNCT03471689
Multisensory Integration and Pain Perception
A study testing Mindfulness meditation and Positive reappraisal in people with Pain and Regulation, Self, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Regulation, Self
- What is being tested?
- Mindfulness meditation and Positive reappraisal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Native/fluent English speaker
- Ability to understand/willingness to sign consent form
Who cannot join
- Chronic pain
- Cardiac medications
- Diagnosis of mental illness or personality disorder
- Diagnosis of heart or lung conditions/hyper tension
- Taking psychiatric medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
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.
- Conditions
- Pain, Regulation, Self
- Being tested
- Mindfulness meditation, Positive reappraisal
- Keywords
- Multimodal, Pain perception, Regulation, Mindfulness
- Medical subject headings
- Pain, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Participants will be trained to use mindfulness meditation to reduce pain perception.
Positive reappraisalBehavioural
Participants will be trained to use positive reappraisal to reduce pain perception.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Not described Receives: Behavioral: Mindfulness meditation |
| Positive reappraisal | Active comparator | Not described Receives: Behavioral: Positive reappraisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: throughout study completion, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start8 Nov 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: Resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Christian Waugh, PhD, Principal investigator, Wake Forest UniversityFadel Zeidan, PhD, Principal investigator, Wake Forest University Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471689
- Sponsor's protocol ID
- IRB00046662
- Status last verified
- Jun 2019
- First submitted
- 12 Mar 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Integration and Pain Perception
- ClinicalTrials.gov ID
- NCT03471689
- Acronym / sponsor ID
- IRB00046662
- Conditions
- Pain, Regulation, Self
- Keywords
- Multimodal, Pain perception, Regulation, Mindfulness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness meditation |
| Positive reappraisal | Active comparator | Behavioral: Positive reappraisal |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Native/fluent English speaker
- Ability to understand/willingness to sign consent form
Key exclusion criteria (5 listed)
- Chronic pain
- Cardiac medications
- Diagnosis of mental illness or personality disorder
- Diagnosis of heart or lung conditions/hyper tension
- Taking psychiatric medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationParticipants will be trained to use mindfulness meditation to reduce pain perception. | Behavioural | Mindfulness |
| Positive reappraisalParticipants will be trained to use positive reappraisal to reduce pain perception. | Behavioural | Positive reappraisal |
Primary outcome
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".
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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Waugh, PhD principal investigator
Wake Forest University
Fadel Zeidan, PhD principal investigator
Wake Forest University Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation and Positive reappraisal in people with Pain and Regulation, Self, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysical Assessment of Pain (time frame: throughout study completion, up to 2 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.