Detection of Electrodermal Activity in Pain 2

Overview

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.