Acute Pain, Emotions, Positive Thinking
Conditions
Brief summary
The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be randomized to a behavioral writing intervention and a cold pressor task. Participants will be randomized to a gratitude or neutral writing condition.
Interventions
BEHAVIORALBehavioral Writing Intervention
This behavioral intervention will require participants to write about certain aspects of their lives.
Sponsors
Black Hills State University
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* must be pain-free * must be at least 18 years old
Exclusion criteria
* cardiovascular disease * Raynaud's disease * epilepsy * being pregnant * having a current injury to or open cut or sore on one's non-dominant hand * history of fainting or seizures * history of frostbite in non-dominant hand * chronic pain conditions (e.g., fibromyalgia, neuropathy, arthritis) * diabetes * malignant tumor * chronic lung disease * liver disease * kidney disease * gastrointestinal diseases * currently taking opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Pain Ratings From Baseline to 10-minutes Post Cold Pressor Test | Baseline to 10 minutes post cold pressor test | Self-reported measures of pain will be reported on a numeric scale of 0 (no pain) to 10 (strongest pain imaginable every 15 seconds throughout a cold pressor test and again 1 minute and 10 minutes post cold pressor test. |
| Differences in Pain Tolerance to Cold Pressor Test | Up to 1.5 minutes of Cold Pressor Test | Pain tolerance will be measured in terms of how many seconds individuals can keep their hand submerged in near-freezing water, for a maximum of up to 90 seconds (the task will be ended at that point). |
| Differences in Pain Onset to Cold Pressor Test | Up to 1.5 minutes of Cold Pressor Test | Pain onset will be measured in seconds between participants submerging their hands into near-freezing water and the self-reported beginning of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Pain-Related Cognition | Immediately after the Cold Pressor Test | The Rumination and Reappraisal subscales from the Pain-Related Cognitive Processes Questionnaire were used to assess the extent to which individuals engaged in various thought processes during the cold pressor test. Each subscale is comprised of 6-items and answered on a 0 (Not at all) to 4 (All or most of the time) scale. Scores on each item are summed to calculate an overall score which can range from 0 to 24, with higher scores indicative of greater use of each cognitive process. |
| Differences in Autonomic Nervous System Responsivity | Baseline to 10 minutes post cold pressor test | Autonomic nervous system responsivity will be assessed using levels of salivary alpha-amylase. Unstimulated whole saliva samples will be collected using the passive drool technique at the following time points: 1) immediately following completion of baseline surveys, 2) immediately following the experimental writing task, 3) 1-minute post-cold pressor test, and 4) 10-minutes post-cold pressor test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNathan Deichert, PhD
Black Hills State University
Participant flow
Recruitment details
Participants were recruited through the Black Hills State University community through posting flyers, electronic newsletters, and in-person announcements.
Pre-assignment details
Given that the intervention consisted of a single visit of approximately 45 minutes, there were no significant events that occurred between enrollment and assignment of participants to an intervention group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.27 Years STANDARD_DEVIATION 8.79 |
| Coping Strategies Questionnaire 24 | 11.85 Units on a Scale STANDARD_DEVIATION 5.47 |
| GAD-7 | 4.69 Units on a Scale STANDARD_DEVIATION 4.36 |
| Perceived Stress Scale | 15.27 Units on a Scale STANDARD_DEVIATION 6.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 112 Participants |
| Self-Reported Smoking Current Smoker | 12 Participants |
| Self-Reported Smoking Data Missing | 0 Participants |
| Self-Reported Smoking Non-Smoker | 69 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 23 Participants |
| Socioeconomic Status Lower Class | 7 Participants |
| Socioeconomic Status Middle Class | 66 Participants |
| Socioeconomic Status Not Reported | 1 Participants |
| Socioeconomic Status Upper Middle and Upper Class | 14 Participants |
| Socioeconomic Status Working Class | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 67 |
| other Total, other adverse events | 1 / 78 | 0 / 67 |
| serious Total, serious adverse events | 0 / 78 | 0 / 67 |
Outcome results
None listed