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NCT Number: NCT06677593

Detection of Electrodermal Activity in Pain 2

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Chronic Disease Chronic Obstructive Pulmonary Disease (COPD Disease Attributes Lung Diseases Lung Diseases, Obstructive Neoplasms Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital - Hvidovre

Hvidovre, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain intensity

    Time frame: while participants wear the device (up to 7 days)

    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.

Secondary outcomes

  1. Skin conductance level

    Time frame: while participants wear the device (up to 7 days)

    The average skin conductance value (μS) for 10 seconds.

  2. Number of Skin Conductance Fluctuations

    Time frame: while participants wear the device (up to 7 days)

    Peaks with minimum amplitudes of 0.02 μS and a slope rate < 2 μS/s, in 10 second intervals

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: administered the day of enrollment

    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.

  4. Pain frequency

    Time frame: while participants wear the device (up to a period of 7 days)

    Number of patient reported pain episodes of pain intensity over 5 (using the NRS pain intensity scale)

  5. Pain evaluation from healthcare personale not possible

    Time frame: in the duration that the participant wears the device (up to 7 days)

    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.

  6. Medication list

    Time frame: while participants wear the device (up to 7 days)

    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.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

Detection of Electrodermal Activity in Pain (DEEP)

Acronym: DEEP 2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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