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CompletedNCT05625776Updated Dec 11, 2023

Effects of Acute Pain on Cognitive Performance in Young Adults

An interventional study of pain delivery with capsaicin and heat and distractor delivery with sensory TENS in Pain, Acute and Cognition, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by University of Delaware · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

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Conditions studied

  • Pain, Acute
  • Cognition

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Keywords

  • acute pain
  • cognition
  • pain
  • cognitive ability
  • young adults
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In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 23 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Abbreviations: HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9.

Inclusion criteria

Inclusion Criteria:

  1. 18-35 years old
  2. Self-identifying as generally medically healthy
  3. Able to read, write and speak English
  4. Able to provide informed consent
  5. Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

Exclusion criteria

Exclusion Criteria:

  1. Resting HR \< 50 or > 100 bpm
  2. Resting BP \< 90/60 or > 140/95 mmHg
  3. 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.
  4. Score on the MoCA \<23
  5. Score on the GAD-7 ≥ 10
  6. Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
  7. Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis
  8. Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
  9. Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
  10. 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
  11. Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months
  12. Taking 4 or more medications
  13. 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.)
  14. Any current or chronic pain condition during the last year, located anywhere in the body
  15. Allergy to capsaicin or hot peppers
  16. Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
  17. Skin sensitivity to soaps/creams/perfumes or to heat
  18. Poor circulation in the area targeted for the painful stimulus
  19. Prior participation in a locomotor learning study in this lab within the last 2 years
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Pain Stimulus

    Capsaicin combined with heat applied to intact skin

    Procedure: pain delivery with capsaicin and heat

  • Active comparator
    Distractor Somatosensory Stimulus

    Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin

    Procedure: distractor delivery with sensory TENS

  • No intervention
    No Stimulus

    Nothing applied to skin

Interventions

  • Procedurepain delivery with capsaicin and heat

    Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful

  • Proceduredistractor delivery with sensory TENS

    Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful

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What researchers measure

Primary outcomes

  1. 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

    Time frame: the change between baseline and delivery (during application of intervention)

  2. 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)

    Time frame: the change between baseline and delivery (during application of intervention)

Secondary outcomes

  1. Conner's Continuous Performance Test (CPT) 3

    response time for letters vs. 'x' stimuli; number of correct inhibited responses

    Time frame: the change between baseline and delivery (during application of intervention)

  2. Hopkins Verbal Learning Test- Revised

    verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall

    Time frame: the change between baseline and delivery (during application of intervention)

  3. Brief Visuospatial Memory Test- Revised

    visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition

    Time frame: the change between baseline and delivery (during application of intervention)

  4. Stroop Test

    response time and number of errors when stating the name of words printed in a congruent, neutral or incongruent color compared to the meaning of the words

    Time frame: the change between baseline and delivery (during application of intervention)

  5. Wisconsin Card Sorting Test

    number of trials taken to deduce the new rule when the rules of a card game are changed without warning and without knowing what any of the rules are

    Time frame: the change between baseline and delivery (during application of intervention)

  6. Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section

    number of words stated that match a certain category or start with a certain letter in a given time period

    Time frame: the change between baseline and delivery (during application of intervention)

  7. NIH Toolbox Picture Sequence

    reproduce the correct sequence of pictures

    Time frame: the change between baseline and delivery (during application of intervention)

  8. NIH Toolbox Flanker

    response time and errors when asked to focus on a single visual stimulus amongst distractors

    Time frame: the change between baseline and delivery (during application of intervention)

  9. NIH Toolbox List Sorting

    recall and sequencing of different visually and orally presented stimuli

    Time frame: the change between baseline and delivery (during application of intervention)

  10. NIH Toolbox Dimension Change Card Sort

    errors selecting the correct dimension upon which to select a card, a cue for which is provided

    Time frame: the change between baseline and delivery (during application of intervention)

  11. NIH Toolbox Pattern Comparison

    errors and time required to determine whether several sets of two pictures are the same or not

    Time frame: the change between baseline and during application of intervention

  12. Wechsler 4th ed - Spatial Addition

    errors and time required to add or subtract the location of circles on a screen based on a given set of rules

    Time frame: the change between baseline and delivery (during application of intervention)

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Study locations

1 site
  • University of Delaware
    Newark, Delaware 19713, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05625776
Lead sponsor
University of Delaware
Collaborators
National Institute on Aging (NIA)
Responsible party
Susanne M Morton (Associate Professor, University of Delaware) — Principal investigator
First posted
Nov 23, 2022
Start date
Mar 22, 2023
Primary completion
Nov 16, 2023
Completion
Nov 16, 2023
Last update
Dec 11, 2023

Study contacts

Susanne M Morton, PhD
principal investigator · University of Delaware

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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