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临床试验/NCT06586086
NCT06586086暂停不适用

The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population

Philadelphia College of Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
60
试验地点
1
主要终点
Pain-Pressure Threshold

研究概览

简要总结

This study recruit individuals who are 18 years of age AND Do NOT have a history of diagnosed anxiety disorders AND Do NOT currently have any area of pain lasting 3 months or longer.

The study will measure discomfort with a controlled application of pressure to different muscles and compare these measures with the individual's score on a standardized assessment of anxiety.

详细描述

Purpose Anxiety in general has been associated with lower (more sensitive) pain-pressure thresholds, however, to the best of the investigators knowledge, no research has attempted to differentiate state versus trait anxiety and their respective impacts on pressure sensitivity.

Trait anxiety is an individuals tendency to appraise situations as threatening, avoid anxiety provoking situations, and demonstrate high baseline physiological arousal. State anxiety is defined as; transient state of arousal subjectively experienced as anxiety; This study's objective is to differentiate the role of each anxiety subscale in systemic sensory perception changes. This data may better allow clinicians to glean accurate data about an individuals baseline symptoms as well as potentially shedding light on state-related changes in pain thresholds.

Objectives The primary objective of this study will be to elucidate the differing relationships of trait anxiety and state anxiety on pain-pressure threshold (PPT.) While other measures exist to gauge potential sensitization to sensory stimuli, PPT is often chosen for research due to the ease of administration and its ability to translate data into practice.

Study Population Target population will be healthy adults age 18+. As will be delineated further in this document, this study will recruit healthy adults such as to minimize potential modifications in sensory perception due to comorbidities, medication etc.

Number of Participants The study will enroll 60 participants to provide more robust statistical power

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18 years of age or older
  • Able to read and complete the STAI-5 questionnaire as written in English

排除标准

  • Pain lasting three months or longer, located anywhere in the body
  • Severe health problem (such as cancer, cardiac, neurologic or psychiatric/anxiety disorders),
  • Current pregnancy and/or gave birth in the last year.
  • Subjects currently taking medication which may impact sensory processing, such as antidepressants, opioids, neuroleptics, anticonvulsive drugs or steroids.
  • Subjects diagnosed with fibromyalgia or other conditions known to reduce muscular pain-pressure thresholds, such as Lyme disease, polymyalgia, Lupus and Rheumatoid Arthritis.

结局指标

主要结局

Pain-Pressure Threshold

时间窗: A single collection session of data for each participant, lasting approximately 30 minutes, performed after completion of the STAI-5. Total Data collection window is 4 months.

Quantitative measurement of the amount of pressure applied at the point when the subject described the pressure as slight discomfort

次要结局

  • State-Trait Anxiety questionnaire (STAI)-5 question form(A single collection session of data for each participant, lasting approximately 5 minutes. Total Data collection window is 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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