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Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. There are many ways to measure pain, both through patient self-report (scales) and objective physiological indicators. However, there is no single, universal tool for measuring pain intensity that is simultaneously reliable, valid, and easy to use. Moreover, there are reports showing that not only the intensity of the unpleasant experience but also the nature of the stimulus can cause different levels of changes in the used indicators and scales. In this project, we will compare two devices used for pain monitoring based on physiological parameters: PainMonitor (Med-Storm, Oslo, Norway) and ANI Monitor (MetroDoloris, Loos, France). PainMonitor is a device that records skin conductance (SC) as an indicator of pain intensity. SC reflects the level of autonomic nervous system arousal. The device automatically analyzes these parameters and provides a numerical indicator of pain intensity/anesthesia level. The ANI Monitor is a device based on the analysis of parasympathetic nervous system activity through heart rate variability analysis. Based on this, the device also assesses the degree of pain intensity and presents it in numerical form. The aim of the project is to investigate the correlation between PainMonitor and ANI as tools for measuring pain intensity in situations where healthy volunteers are exposed to various unpleasant stimuli.
The study will involve approximately 100 healthy adult participants who will be exposed to three types of standardized stimuli: thermal (hot and cold), mechanical (pressure from a blood pressure cuff, pressure on a skin fold), chemical (spicy taste), and visual. Simultaneously, they will be monitored by PainMonitor, ANI, ECG, and peripheral perfusion index (using pulse oximetry). This data will then be compared and subjected to statistical analysis to determine if there is a relationship between the nature of the stimuli used and the objective and subjective indicators of pain intensity.
Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Participants will be exposed to unpleasant stimuli, and their response will be determined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimuli | Behavioral | Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Monitor Measurements. | Skin conductance will be recorded using PainMonitor (Med-Storm, Oslo, Norway) - on the non-dominant hand. | Continuously throughout whole study - approximately 1.5 hours |
| Heart rate and its variability (HRV) - high frequencies | Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match high frequency band (0.15 to 0.4 Hz) will be recorded. | Continuously throughout whole study - approximately 1.5 hours |
| Heart rate and its variability (HRV) - low frequencies | Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match low frequency band (0.04 to 0.15 Hz) will be recorded. | Continuously throughout whole study - approximately 1.5 hours |
| The analgesia-nociception index (ANI) | The analgesia-nociception index (ANI) will be recorded using a dedicated device (MetroDoloris, Loos, France). | Continuously throughout whole study - approximately 1.5 hours |
| Perfusion index (PI) | Perfusion index (PI) will be recorded using the pulse oximeter of the Phillips IntelliVue monitor - index finger of the non-dominant hand. | Continuously throughout whole study - approximately 1.5 hours |
| Subjective discomfort/pain - NRS | Subjective discomfort/pain will be monitored using the Numerical Rating Scale (NRS, 0-10). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdansk - Departament of Anesthesiology and Intensive Care | Gdansk | Pomeranian Voivodeship | 80-210 | Poland |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000080762 | Stimuli Responsive Polymers |
| ID | Term |
|---|---|
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D000080745 | Smart Materials |
| D001697 | Biomedical and Dental Materials |
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|
| After each stimuli - approximately 1.5 hours |
| Subjective discomfort/pain - McGill Pain Questionnaire | Subjective discomfort/pain will be monitored using the McGill Pain Questionnaire (SF-MPQ). | After each stimuli - approximately 1.5 hours |
| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |