- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06317844
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
March 30, 2026 updated by: Black Hills State University
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain and the Moderating Effects of COMT Genotype on These Associations
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
145
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
-
-
South Dakota
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Spearfish, South Dakota, United States, 57799
- Black Hills State 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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
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: Gratitude Writing
In the gratitude writing condition, participants will write continuously for 5 minutes about someone they are grateful for.
|
This behavioral intervention will require participants to write about certain aspects of their lives.
|
|
Placebo Comparator: Neutral Writing
Participants in the neutral writing condition will write continuously for 5 minutes about how they got to the research laboratory.
|
This behavioral intervention will require participants to write about certain aspects of their lives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in Pain Tolerance to Cold Pressor Test
Time Frame: 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).
|
Up to 1.5 minutes of Cold Pressor Test
|
|
Differences in Pain Onset to Cold Pressor Test
Time Frame: 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.
|
Up to 1.5 minutes of Cold Pressor Test
|
|
Change in Subjective Pain Ratings From Baseline to 10-minutes Post Cold Pressor Test
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in Autonomic Nervous System Responsivity
Time Frame: 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.
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Baseline to 10 minutes post cold pressor test
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Differences in Pain-Related Cognition
Time Frame: 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.
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Immediately after the Cold Pressor Test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathan Deichert, PhD, Black Hills State University
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)
September 10, 2024
Primary Completion (Actual)
August 19, 2025
Study Completion (Actual)
August 19, 2025
Study Registration Dates
First Submitted
March 6, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BlackHillsHealthPsych
- P20GM103443 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All IPD that underlie results will be in a publication.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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