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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
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The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to create an algorithm that detects pain and provides timely alarms for rising pain levels in patients with life-threatening illnesses suffering from persistent pain. The study is exploratory.
Hypothesis: Electrodermal activity can distinguish different pain intensity levels in patients with chronic pain and a life-threatening disease.
Methodology: Thirty-seven patients with cancer and/or chronic obstructive pulmonary disease (COPD) will be identified through hospital record screening. These patients will wear a monitoring device for a maximum of one week and report their pain intensity throughout the day.
Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain. This study is exploratory, generating hypotheses for subsequent phases of the project.
Methods The study is a phase 2 trial, preceded by a phase 1 trial that included healthy volunteers.
Patients will be inpatients and outpatients at Department of Pulmonary and Endocrine Diseases, Hvidovre Hospital.
Measures Subjective measures (self reported) Pain. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
Patient Health Status. The Patient Health Questionnaire (PHQ-9) is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The PHQ-9 is the depression module.
Ambulatory assessment. The patient group in phase 2 will be asked to wear a wristband device for 1 week. During this period, a prompt will be sent on a smartphone connected to a wearable device provided by Movisens GmbH, five times a day (9 am, 12 pm, 3 pm, 6 pm, and 9 pm) to answer questions about their current pain levels using the NRS scale.
Objective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).
Wearable device The EdaMove 4 device provided by Movisens GmbH consists of an EDA and activity sensor. It records EDA signals to monitor both tonic and phasic electrical activity in the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with COPD or cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Numerical rating scale score. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain. | while participants wear the device (up to 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin conductance level | The average skin conductance value (μS) for 10 seconds. | while participants wear the device (up to 7 days) |
| Number of Skin Conductance Fluctuations | Peaks with minimum amplitudes of 0.02 μS and a slope rate < 2 μS/s, in 10 second intervals |
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Inclusion Criteria:
Exclusion Criteria:
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Hvidovre Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Kirstine S Benthien, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Hvidovre | Hvidovre | Denmark |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D010146 | Pain |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| while participants wear the device (up to 7 days) |
| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) will be used to screen participants as symptoms of depression in order to control during the statistical analysis. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), providing a 0 to 27 severity score. | administered the day of enrollment |
| Pain frequency | Number of patient reported pain episodes of pain intensity over 5 (using the NRS pain intensity scale) | while participants wear the device (up to a period of 7 days) |
| Pain evaluation from healthcare personale not possible | Evaluate how often it is not possible to estimate pain levels for patients, thus, a need for a tool to assist). This is marked at the patient journal. | in the duration that the participant wears the device (up to 7 days) |
| Medication list | The list of medication a participant takes on regular basis during the week they will be assessed. This data will be collected from the patient journals to control and to understand the final dataset. | while participants wear the device (up to 7 days) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |