Detection of Electrodermal Activity in Pain 1

NCT06678217 | Active Not Recruiting

• 1 other identifier: H-24037808-Phase-1
• Study Type: interventional
• 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 develop an algorithm that detects pain-related changes in electrodermal activity in healthy volunteers undergoing a cold pressor test. The study is exploratory. The main research questions are: Can pain be detected using electrodermal activity, and do psychological variables, including stress, affect the electrodermal response to pain? Study Design: The study has two arms. Methodology: Thirty-seven healthy volunteers perform an experimental pain task while their electrodermal activity is recorded and complete questionnaires. The participants are randomized 1:1 to either the cold pressor test alone or the cold pressor test combined with a mild experimental stressor (Stroop task). Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain levels. Secondary outcomes include assessing the influence of the mild stressor on the pain response. This study is exploratory, generating hypotheses for subsequent phases of the project.

Conditions

Healthy; Acute 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 have their wrist immersed in cold water for the Cold Pressor Test, for maximum 3 minutes.

Secondary Outcomes (5)

• Skin conductance level

  while participants wear the device throughout testing, which lasts up to fifteen minutes.

• Number of Skin Conductance Fluctuations

  while participants wear the device throughout testing, which lasts up to fifteen minutes.

• Cold pressor endurance time

  while participants have their wrist immersed in cold water for the Cold Pressor Test

• The Patient Health Questionnaire (PHQ-9)

  administered the day of testing

• Pain Catastrophizing

  administered the day of testing

Study Arms (2)

CPT only

EXPERIMENTAL

Participants go through the cold pressor test.

Other: Cold pressor test

CPT and Stroop

EXPERIMENTAL

Participants go through the Stroop task before the cold pressor test.

Other: Stroop task; Other: Cold pressor test

Interventions

Stroop task OTHER

The Stroop task will be used as a mild, acute stressor since it has effects on anxiety and autonomic response. In each Stroop task condition, four coloured visual stimuli will be presented on a computer screen for 3 s with 7 s inter-stimulus interval. The stimuli will be coloured words naming the colour of the ink in the nonconflict task condition (e.g. GREEN written in green ink) and a different colour in the conflict task condition (e.g. GREEN written in red ink). The participants were asked to name the colour of the stimuli. The test will be administered using the online version of PsyToolKit (Stoet, 2021).

CPT and Stroop

Cold pressor test OTHER

The participant lowers their hand in icy water to induce temporary tonic pain

CPT and Stroop; CPT only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Danish
• Age over 18

You may not qualify if:

• Presence of current pain
• Current use of analgesic medication
• Persistent or recurrent pain that exists for longer than 3 months
• Blood circulation or cardiovascular disorders
• Hypertension
• A skin condition on the to-be-tested body parts
• Raynaud syndrome
• Substance abuse
• Pregnancy or lactation and
• A current diagnosis with psychological/ psychiatric disorders
• Diagnosed with chronic illness
• Symptoms of an infectious disease
• 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

Acute Pain; Pain

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Kirstine Skov Benthien, PhD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 7, 2024
• Study Start: November 10, 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)