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临床试验/NCT00678665
NCT00678665Unknown不适用

Initial Study for the Definition in Heart Rate Changes in Response to Heat Pressure and Neural Stimulation

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1

研究概览

简要总结

Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an important factor in patients' recovery and quality of life. Pain is charted today as one of the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score (facial or numerical), by which the patient himself indicates the level of the pain he or she endures. It has been found that the correlation between the reported pain by the patient and the assessed pain by the caregivers or the medical personnel becomes poor as pain intensifies.

Objective assessment of anesthesia using the heart rate and its spectral analyses was done in the past. By using this modality, works on neonatal pain were conducted. In adults, works have shown that there is possibility to assess pain using this modality, though no repeated proof for its ability to detect pain was published.

We know that physiological signals such as ECG consist of mixtures of variety of patterns and phenomena accruing at different patterns and time points. Traditional analysis methods are designed and optimized to handle signals that include a single class of patterns such as pure harmonics or piece-wise constant functions. However, such basic operations that use a single representation method usually yield mediocre results when applied to real complex biological signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very low. Recent trends in digital signal processing (DSP) use the novel idea of merging several different representation methods to create a so called over-complete dictionary, examples of this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We intend to develop and apply the novel signal processing tools to the ECG signals for the first time. We believe that such tools have the potential to provide much better insight of the signal basic components and their relation to pain.

详细描述

Background:

Pain Assessment:

Whereas temperature, pulse, respirations, and blood pressure are all objectively measured, pain is inherently subjective. Given this fundamental difficulty, it is no wonder that failure to properly assess pain is a common cause of its poor control and lack of treatment in patients in different settings (1). Moreover, pain is multidimensional, with "sensory-discriminatory, cognitive-evaluative, and affective-motivational" components (2), or in other words, it affects body, mind, and spirit, and its complexity makes it hard to measure (1). Since pain has been recognized as an important modality, influencing recovery and quality of life in patients, it has been termed "the fifth vital sign" and is now being evaluated and registered in the patients' charts during routine checkups. Pain itself is repeatedly rated by the patients and the caregivers or the medical personnel, it is followed and treated.

For routine standardization, pain is charted on a scale of 0(no pain) to 10 (worst pain possible). At pain intensities of 0 to 4 patients describe the interference with function as mild (as reflected in daily activities and mood), at 5 to 6 it is described as moderate, and at 7 to 10 as severe (2). For standard scaling, different assessment tools were developed. One-dimensional pain scales, in which the patient is asked to describe the intensity of pain, are the most used tool today (1). These are the VAS- Visual analog Score (e.g., the patient places a mark on a 10-cm line to indicate the intensity of pain; one end of the line is labeled "no pain" and the other "the worst possible pain"), the Numeric ("please rate the intensity of pain on a scale of 1 to 10") and the Categorical ("please rate the pain as none, mild, moderate, or severe"). These scales are reliable and valid and can be used in conjunction with the World Health Organization (WHO) analgesic ladder guideline. (3)

The one-dimensional intensity scales can be modified to produce a pain relief scale, a patient pain satisfaction scale, or a pain management index (4). Moreover, comprehensive multidimensional pain assessment tools such as the Brief Pain Inventory were developed to help pain management specialist's measure and assess the effect of pain on mood, activities, and quality of life-which one-dimensional tools cannot do. (2) These tools are more difficult for the patients and the medical personnel to complete and are usually not used in daily practice (1).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy 20-40 years old subjects

排除标准

  • •Heart deseases cardiovascular nedications hypertension neurological disorders

研究者

申办方类型
Other

研究点 (1)

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