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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103443 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gratitude Writing | Experimental | In the gratitude writing condition, participants will write continuously for 5 minutes about someone they are grateful for. |
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| Neutral Writing | Placebo Comparator | Participants in the neutral writing condition will write continuously for 5 minutes about how they got to the research laboratory. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Writing Intervention | Behavioral | This behavioral intervention will require participants to write about certain aspects of their lives. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Pain Ratings From 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. | Baseline to 10 minutes post cold pressor test |
| Differences in Pain Tolerance to 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). | Up to 1.5 minutes of Cold Pressor Test |
| Differences in Pain Onset to 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. | Up to 1.5 minutes of Cold Pressor Test |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Pain-Related Cognition | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Deichert, PhD | Black Hills State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Black Hills State University | Spearfish | South Dakota | 57799 | United States |
All IPD that underlie results will be in a publication.
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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.
Participants were recruited through the Black Hills State University community through posting flyers, electronic newsletters, and in-person announcements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gratitude Writing | Participants completed baseline questionnaires followed by a 5-minute gratitude writing task, during which time participants wrote continuously for 5 minutes about someone they are grateful for. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
| FG001 | Neutral Writing | Participants completed baseline questionnaires followed by a 5-minute neutral writing task, during which time participants wrote continuously for 5 minutes about how they got to the research laboratory. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gratitude Writing | Participants completed baseline questionnaires followed by a 5-minute gratitude writing task, during which time participants wrote continuously for 5 minutes about someone they are grateful for. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self-Reported Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Subjective Pain Ratings From 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. | Individuals were included in the repeated-measures analysis only if they completed the 90-second cold-pressor test (CPT) | Posted | Mean | Standard Error | Units on a Scale | Baseline to 10 minutes post cold pressor test |
|
Adverse events were monitored from baseline through completion of the intervention. Participants reporting an adverse event during the intervention were followed for up to 24 hours after completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gratitude Writing | Participants completed baseline questionnaires followed by a 5-minute gratitude writing task, during which time participants wrote continuously for 5 minutes about someone they are grateful for. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant experienced lightheadedness, nausea, and dizziness. | Cardiac disorders | Non-systematic Assessment | Participant self-reported symptoms after the cold pressor test (CPT). The event was assessed as mild in severity and may have been due to the CPT. The participant reported recovering when contacted several hours after the intervention was ended. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Deichert | Black Hills State University | 6056426544 | nathan.deichert@bhsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2024 | Mar 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2024 | Feb 26, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2024 | Mar 2, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Immediately after the Cold Pressor Test |
| Differences in Autonomic Nervous System Responsivity | 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. | Baseline to 10 minutes post cold pressor test |
| BG001 | Neutral Writing | Participants completed baseline questionnaires followed by a 5-minute neutral writing task, during which time participants wrote continuously for 5 minutes about how they got to the research laboratory. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Self-Reported Sex Assigned at Birth | Count of Participants | Participants |
|
| Race (NIH/OMB) | Self-Reported Race | Count of Participants | Participants | No |
|
| Socioeconomic Status | Participants self reported their perceived socioeconomic status | Count of Participants | Participants |
|
| Perceived Stress Scale | Perceived stress scores can range from 10 to 40 with higher scores indicative of greater perceived stress at baseline. | Mean | Standard Deviation | Units on a Scale |
|
| GAD-7 | The GAD-7 measures self-reported symptoms of anxiety with scores ranging from 0 to 21, with higher scores indicating greater baseline anxiety. | Mean | Standard Deviation | Units on a Scale |
|
| Coping Strategies Questionnaire 24 | The pain catastrophizing score on the CSQ-24 measures the extent to which participants engage in pain-related catastrophizing when coping with pain. Scores on this subscale can range from 6 to 42, with higher scores indicating individuals engage in more catastrophic thinking patterns. | Mean | Standard Deviation | Units on a Scale |
|
| Self-Reported Smoking | Count of Participants | Participants |
|
| OG001 | Neutral Writing | Participants completed baseline questionnaires followed by a 5-minute neutral writing task, during which time participants wrote continuously for 5 minutes about how they got to the research laboratory. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. |
|
|
| Primary | Differences in Pain Tolerance to 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). | Participants were excluded from the data analysis if they were missing data on covariates. | Posted | Mean | Standard Error | Seconds | Up to 1.5 minutes of Cold Pressor Test |
|
|
|
| Primary | Differences in Pain Onset to 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. | Participants were excluded from the data analysis if they did not report pain onset or if they were missing values on covariates. | Posted | Mean | Standard Error | Seconds | Up to 1.5 minutes of Cold Pressor Test |
|
|
|
| Secondary | Differences in Pain-Related Cognition | 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. | Participants were excluded from the data analysis if they were missing data on covariates. | Posted | Mean | Standard Error | Units on a Scale | Immediately after the Cold Pressor Test |
|
|
|
| Secondary | Differences in Autonomic Nervous System Responsivity | 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. | Participants were excluded from the data analysis if they were missing data on covariates. | Posted | Mean | Standard Error | U/mL | Baseline to 10 minutes post cold pressor test |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 1 |
| 78 |
| EG001 | Neutral Writing | Participants completed baseline questionnaires followed by a 5-minute neutral writing task, during which time participants wrote continuously for 5 minutes about how they got to the research laboratory. Participants then underwent a cold pressor test with subjective pain ratings recorded every 15 seconds. Post-task cognitions were assessed. Saliva samples were collected following completion of baseline measures, the writing intervention, and 2- and 10-minutes post-CPT. | 0 | 67 | 0 | 67 | 0 | 67 |
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| sAA 2-Minutes Post-CPT |
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| sAA 10-Minutes Post-CPT |
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