Clinical trial NCT06677593: Detection of Electrodermal Activity in Pain 2
Official title: Detection of Electrodermal Activity in Pain (DEEP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Chronic Obstructive Pulmonary Disease (COPD
Pain
Keywords: pain
electrodermal activity
pain detection
pain prediction
galvanic skin response
wearable
pain monitoring
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2024-11-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hvidovre Hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Danish
* Age over 18
* Persistent or recurrent pain (longer than three months)
* Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47

Exclusion Criteria:

* A current diagnosis with psychological/ psychiatric disorders
* Impaired cognitive function
* Substance abuse
* A skin condition on the to-be-tested body parts
* PHQ-9 reveals suicidal ideation

Primary outcomes:
measure: Pain intensity
timeFrame: while participants wear the device (up to 7 days)
Secondary outcomes:
measure: Skin conductance level
timeFrame: while participants wear the device (up to 7 days)
measure: Number of Skin Conductance Fluctuations
timeFrame: while participants wear the device (up to 7 days)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: administered the day of enrollment
measure: Pain frequency
timeFrame: while participants wear the device (up to a period of 7 days)
measure: Pain evaluation from healthcare personale not possible
timeFrame: in the duration that the participant wears the device (up to 7 days)
measure: Medication list
timeFrame: while participants wear the device (up to 7 days)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital - Hvidovre
Study officials:
affiliation: University of Copenhagen
name: Kirstine S Benthien, PhD
role: PRINCIPAL_INVESTIGATOR
References: