Examination of Psychological and Physiological Pathways Linking Gratitude and Pain

Acute Pain Clinical Trial

Official title:

Examination of Psychological and Physiological Pathways Linking Gratitude and Pain and the Moderating Effects of COMT Genotype on These Associations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317844
• Other study ID #: BlackHillsHealthPsych
• Secondary ID: P20GM103443
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Black Hills State University
• Contact: Nathan T Deichert, PhD
• Phone: 6056426544
• Email: nathan.deichert[@]bhsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emotions

Intervention

Behavioral:
• Behavioral Writing Intervention
This behavioral intervention will require participants to write about certain aspects of their lives.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Black Hills State University	National Institute of General Medical Sciences (NIGMS)

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 10 minutes post cold pressor test
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).	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.	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 will be 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.	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.	Baseline to 10 minutes post cold pressor test