NCT05625776已完成不适用
Effects of Acute Pain on Cognitive Performance in Young Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Digit Span Forward & Backward Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Application of pain or attentional control or no stimulus cannot be masked from participants, nor from outcomes assessors.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 -
- •Inclusion Criteria:
- •18-35 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
排除标准
- •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
- •Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
- •Skin sensitivity to soaps/creams/perfumes or to heat
- •Poor circulation in the area targeted for the painful stimulus
- •Prior participation in a locomotor learning study in this lab within the last 2 years
研究组 & 干预措施
Pain Stimulus
Experimental
Capsaicin combined with heat applied to intact skin
干预措施: pain delivery with capsaicin and heat (Procedure)
Distractor Somatosensory Stimulus
Active Comparator
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
干预措施: distractor delivery with sensory TENS (Procedure)
No Stimulus
No Intervention
Nothing applied to skin
结局指标
主要结局
Digit Span Forward & Backward Test
时间窗: the change between baseline and delivery (during application of intervention)
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
Trail Making Test A & B
时间窗: the change between baseline and delivery (during application of intervention)
time required to draw a line connecting a series of numbers (TM-A) or a series of alternating letters and numbers (TM-B)
次要结局
- 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))
- Conner's Continuous Performance Test (CPT) 3(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))
- NIH Toolbox List Sorting(the change between baseline and delivery (during application of intervention))
- NIH Toolbox Flanker(the change between baseline and delivery (during application of intervention))
- Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section(the change between baseline and delivery (during application of intervention))
- NIH Toolbox Dimension Change Card Sort(the change between baseline and delivery (during application of intervention))
- Wechsler 4th ed - Spatial Addition(the change between baseline and delivery (during application of intervention))
- NIH Toolbox Picture Sequence(the change between baseline and delivery (during application of intervention))
- NIH Toolbox Pattern Comparison(the change between baseline and during application of intervention)
研究者
Susanne M Morton
Associate Professor
University of Delaware
研究点 (1)
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