Effects of Acute Pain on Cognitive Performance in Young Adults
2 other identifiers
interventional
23
1 country
1
Brief Summary
The effects of pain on cognitive performance have not been thoroughly investigated. Broadly, the purpose of this research is to investigate the effects of acute pain on performance of a variety of cognitive performance measures. The investigators hypothesize that acute pain impairs cognitive performance, particularly cognitive measures of working memory, attention, and processing speed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2023
CompletedDecember 11, 2023
December 1, 2023
8 months
November 13, 2022
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Digit Span Forward & Backward Test
number of digits (numbers) that can be repeated back in the same (DS forward) or the reverse (DS backward( order from which they were presented
the change between baseline and delivery (during application of intervention)
Trail Making Test A & B
time required to draw a line connecting a series of numbers (TM-A) or a series of alternating letters and numbers (TM-B)
the change between baseline and delivery (during application of intervention)
Secondary Outcomes (12)
Conner's Continuous Performance Test (CPT) 3
the change between baseline and delivery (during application of intervention)
Hopkins Verbal Learning Test- Revised
the change between baseline and delivery (during application of intervention)
Brief Visuospatial Memory Test- Revised
the change between baseline and delivery (during application of intervention)
Stroop Test
the change between baseline and delivery (during application of intervention)
Wisconsin Card Sorting Test
the change between baseline and delivery (during application of intervention)
- +7 more secondary outcomes
Study Arms (3)
Pain Stimulus
EXPERIMENTALCapsaicin combined with heat applied to intact skin
Distractor Somatosensory Stimulus
ACTIVE COMPARATORSensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
No Stimulus
NO INTERVENTIONNothing applied to skin
Interventions
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful
Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful
Eligibility Criteria
You may qualify if:
- years old
- Self-identifying as generally medically healthy
- Able to read, write and speak English
- Able to provide informed consent
- Willing to undergo the experimental pain or non-painful electrical stimulation, if selected
You may not qualify if:
- Resting HR \< 50 or \> 100 bpm
- Resting BP \< 90/60 or \> 140/95 mmHg
- Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
- Score on the MoCA \<23
- Score on the GAD-7 ≥ 10
- Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
- Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis
- Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
- Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
- History of serious concussion or head injury, defined as a loss of consciousness for \> 5 minutes and/or requiring medical treatment, or \> 2 concussions over the lifespan
- Any history of acute or chronic problems with balance, any dizziness, or \> 1 fall in the last 12 months
- Taking 4 or more medications
- Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
- Any current or chronic pain condition during the last year, located anywhere in the body
- Allergy to capsaicin or hot peppers
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Delawarelead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Delaware
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne M Morton, PhD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Application of pain or attentional control or no stimulus cannot be masked from participants, nor from outcomes assessors.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 13, 2022
First Posted
November 23, 2022
Study Start
March 22, 2023
Primary Completion
November 16, 2023
Study Completion
November 16, 2023
Last Updated
December 11, 2023
Record last verified: 2023-12