Acute PainNCT06317844

Examination of Psychological and Physiological Pathways Linking Gratitude and Pain

A study testing Behavioral Writing Intervention in people with Acute Pain and Positive Thinking, run by Black Hills State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Acute Pain, Positive Thinking, Emotions
What is being tested?: Behavioral Writing Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 145 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2024to 19 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

must be pain-free
must be at least 18 years old

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Black Hills State University
Spearfish, South Dakota, 57799

Other trials in United States

About this study

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

Read the 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.

Conditions: Acute Pain, Positive Thinking, Emotions
Being tested: Behavioral Writing Intervention
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06317844
Study group	Role	What they receive
Gratitude Writing	Experimental	In the gratitude writing condition, participants will write continuously for 5 minutes about someone they are grateful for. Receives: Behavioral: Behavioral Writing Intervention
Neutral Writing	Placebo comparator	Participants in the neutral writing condition will write continuously for 5 minutes about how they got to the research laboratory. Receives: Behavioral: Behavioral Writing Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: Up to 1.5 minutes of Cold Pressor Test

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline to 10 minutes post cold pressor test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202419 Aug 2025

First posted19 Mar 2024
Study start10 Sep 2024
Primary completion19 Aug 2025
Study completion19 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute 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: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06317844
Sponsor's protocol ID: BlackHillsHealthPsych
Other IDs: P20GM103443
Status last verified: Mar 2026
First submitted: 6 Mar 2024
Last updated: 17 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: All IPD that underlie results will be in a publication.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of Psychological and Physiological Pathways Linking Gratitude and Pain and the Moderating Effects of COMT Genotype on These Associations
ClinicalTrials.gov ID: NCT06317844
Acronym / sponsor ID: BlackHillsHealthPsych
Conditions: Acute Pain, Positive Thinking, Emotions
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Black Hills State UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 10 Sep 2024 (actual)
Primary completion: 19 Aug 2025 (actual)
Study completion: 19 Aug 2025 (actual)
First posted: 19 Mar 2024 (actual)
Results: Posted 17 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gratitude Writing	Experimental	Behavioral: Behavioral Writing InterventionIn the gratitude writing condition, participants will write continuously for 5 minutes about someone they are grateful for.
Neutral Writing	Placebo comparator	Behavioral: Behavioral Writing InterventionParticipants in the neutral writing condition will write continuously for 5 minutes about how they got to the research laboratory.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

must be pain-free
must be at least 18 years old

Key exclusion criteria (15 listed)

cardiovascular disease
Raynaud's disease
epilepsy
being pregnant
having a current injury to or open cut or sore on one's non-dominant hand

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
Behavioral Writing InterventionThis behavioral intervention will require participants to write about certain aspects of their lives.	Behavioural	Gratitude Writing, Neutral Writing

Primary outcome

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.
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).
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.

2 secondary outcomes

Differences in Pain-Related Cognition
Time frame: Immediately after the Cold Pressor Test
Differences in Autonomic Nervous System Responsivity
Time frame: Baseline to 10 minutes post cold pressor test

Results and safety

Results posted to the registry on 17 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gratitude Writing	78	77
Neutral Writing	67	67

Primary outcome: Change in Subjective Pain Ratings From Baseline to 10-minutes Post Cold Pressor Test

Time frame: Baseline to 10 minutes post cold pressor test. Mean (Standard Error). Unit: Units on a Scale

Measure	Gratitude Writing n = 43	Neutral Writing n = 45
Baseline Pain Rating	.002 (.015)	.020 (.015)
Pain Rating at 15 Seconds	3.23 (.309)	2.55 (.302)
Pain Rating at 30 Seconds	4.63 (.34)	3.86 (.33)
Pain Rating at 45 Seconds	5.86 (.37)	5.00 (.36)
Pain Rating at 60 Seconds	6.52 (.38)	5.73 (.37)
Pain Rating at 75 Seconds	6.98 (.36)	6.23 (.36)
Pain Rating at 90 Seconds	7.32 (.36)	6.36 (.35)
Pain Rating 2-Minutes Post-CPT	1.42 (.21)	1.52 (.21)

Population analysed: Individuals were included in the repeated-measures analysis only if they completed the 90-second cold-pressor test (CPT)

Primary outcome: Differences in Pain Tolerance to Cold Pressor Test

Time frame: Up to 1.5 minutes of Cold Pressor Test. Mean (Standard Error). Unit: Seconds

Measure	Gratitude Writing n = 74	Neutral Writing n = 65
Value	73.310 (2.855)	76.817 (3.604)

Population analysed: Participants were excluded from the data analysis if they were missing data on covariates.

Primary outcome: Differences in Pain Onset to Cold Pressor Test

Time frame: Up to 1.5 minutes of Cold Pressor Test. Mean (Standard Error). Unit: Seconds

Measure	Gratitude Writing n = 64	Neutral Writing n = 54
Value	14.847 (2.359)	18.521 (3.062)

Population analysed: Participants were excluded from the data analysis if they did not report pain onset or if they were missing values on covariates.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gratitude Writing	0 of 78 (0%)	1 of 78 (1.3%)	0 of 78
Neutral Writing	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. All IPD that underlie results will be in a publication.

Related trials for Acute Pain

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Acute Pain, Postoperative Pain, Acute
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Not yet recruiting
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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.

Nathan Deichert, PhD principal investigator

Black Hills State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Writing Intervention in people with Acute Pain and Positive Thinking, run by Black Hills State University 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 15 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: finished, as of the sponsor's last update on 17 Apr 2026. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Subjective Pain Ratings From Baseline to 10-minutes Post Cold Pressor Test (time frame: Baseline to 10 minutes post cold pressor test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06317844.

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 17 Apr 2026.