Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
37 participants
OBSERVATIONAL
2024-11-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients with COPD or cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age over 18
* Persistent or recurrent pain (longer than three months)
* Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47
Exclusion Criteria
* Impaired cognitive function
* Substance abuse
* A skin condition on the to-be-tested body parts
* PHQ-9 reveals suicidal ideation
18 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Responsible Party
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Kirstine Skov Benthien
Principal Investigator
Principal Investigators
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Kirstine S Benthien, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Copenhagen University Hospital - Hvidovre
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-24037808-Phase-2
Identifier Type: -
Identifier Source: org_study_id
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