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临床试验/NCT04053608
NCT04053608Unknown不适用

Observation of In-Hospital/ In-Home Continuous Monitoring of Human Physiology and Self-Reported Pain Score Among Patients With Moderate-to-severe Cancer Pain

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Pain Reporting by pain intensity and body map

研究概览

简要总结

To assess whether the patient's self-reported pain level is associated with a multivariate physiological biomarker bias achieved in the actual clinical setting. This study will use a clinical-grade wearable sensor to continuously monitor the patient's physiological condition (pain-related biomarkers) and use the mobile app to allow participants to actively report their pain scores, symptoms and quality of life.After analysis of the biomarkers we may predict the coming pain attacks by way of the meaningful biomarkers.

详细描述

Subjective scores have traditionally been used to measure human pain, such as the visual analog scale (VAS) to determine the presence or absence of pain and its severity. People can only express the pain experienced by dictation, scale, and image depicting the degree of pain. Although this is important information, the self-evaluation method has problems for diagnosis and research purposes. The results of a person's self-assessment depend on past pain experiences and many other cognitive and behavioral factors and therefore change over time. In addition, it is difficult to obtain a reliable comparison between the rewards of different people. When the patient complains of a certain degree of pain, it is impossible to know whether it is equivalent to the same pain described by other patients. Moreover, it is difficult to obtain self-evaluation results among ethnic groups of different natures, such as young people, patients who block the transmission of ideas due to different disease types, and those who are unconscious. A variety of survey-based pain scales and functions have been developed recently, and the utility has improved.

However, because it is still based on self-assessment, it will leave some of the same problems with self-assessment. Developmental measurements of biomarkers or surrogate markers with acute and/or chronic pain have made significant progress over the past few years. Thanks to the development of new and improved technologies, such as in the field of angiography and wearable biosensors, there has been considerable development. Studies have shown that pupils respond to a variety of different stimuli and may predict the presence of pain. There are many different physiological parameters, such as changes in heart rate, pulsating components of the heart cycle, and skin activity, which have been shown to be associated with the presence or absence of pain. From the development of research in this field, it is feasible to develop clinical tools for measuring the presence or absence of acute and/or chronic pain, including cancer pain, using biomarkers or surrogate markers. This objective tool can make more significant advances in clinical pain research and treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).
  • Inclusion conditions:
  • Male and female between the ages of 21 and 70
  • Cancer patients diagnosed with moderate to severe cancer pain (digital rating scale NRS ≥ 4)
  • Ability to provide informed consent
  • Be able to commit to using the app during the study and input data as needed
  • The subject must have a smart phone such as an iPhone/iPad (at least iPhone 5S)

排除标准

  • Previously had myocardial infarction (MI)
  • Coronary artery disease is known - previous coronary angioplasty
  • A previous stroke occurred, and stroke was defined as a new localized nerve defect lasting more than 24 hours.
  • Currently using more than 2 kinds of blood pressure lowering drugs
  • Expected life is less than 1 year
  • Suffering from asthma or chronic lung disease requires long-term medication or oxygen therapy
  • suffering from mental illness, the clinical judgment of the host will affect the participation of the trial, such as dementia
  • Unable to comply with the test plan
  • Any other acute or chronic medical/physiological condition identified by the moderator as affecting the test results

结局指标

主要结局

Pain Reporting by pain intensity and body map

时间窗: 30days

Patient will report pain intensity in Numerical Rating Scale (NRS) from 0-10 through smartphone and when they suffer from pain. If possible they will type in the medications they take when they suffer from moderate (NRS\>=4) to severe pain (NRS\>=7). Besides, they may choosing the location of pain using a validated body map and logging the time the pain event took place to the nearest 15 minutes.

次要结局

  • Symptom Reporting and record of EQ-5D-3L (Quality of Life Questionnaire)(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chih-Cheng Wu

Head of Pain medicine division, department of anesthesiology

Taichung Veterans General Hospital

研究点 (1)

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