Detection of Electrodermal Activity in Pain 2

NCT06677593 | Active Not Recruiting

• 1 other identifier: H-24037808-Phase-2
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chronic Obstructive Pulmonary Disease (COPD; Pain

Keywords

pain; electrodermal activity; pain detection; pain prediction; galvanic skin response; wearable; pain monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Skin conductance level

  while participants wear the device (up to 7 days)

• Number of Skin Conductance Fluctuations

  while participants wear the device (up to 7 days)

• Patient Health Questionnaire (PHQ-9)

  administered the day of enrollment

• Pain frequency

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

• Pain evaluation from healthcare personale not possible

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

Study Arms (1)

Patients

Patients with COPD or cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hvidovre Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital - Hvidovre

Hvidovre, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Pulmonary Disease, Chronic Obstructive; Pain

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kirstine S Benthien, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)