Detection of Electrodermal Activity in Pain 1

NCT ID: NCT06678217

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-12-31

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.

Detailed Description

Methods Research Design The purpose of phase 1 is to develop an algorithm to assess and predict pain using biological signals and self-reported outcome measures. For phase 1, a randomized controlled trial design will be used. Group 1 will undergo the Cold Pressor Test (CPT) only, while Group 2 will undergo the CPT in addition to the Stroop task.

Measures Subjective measures (Self-Reported) Pain. Pain intensity (interval, 0 to 10) is measured using the numerical rating scale (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.

Pain Catastrophizing. It is measured using the Pain Catastrophizing Scale (PCS). This scale is short, and consists of 13-items scored on a 5-point Likert scale from 0 (not at all) to 4 (all the time).

Patient Health Status. The Patient Health Questionnaire is commonly used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The PHQ-9 is the depression module.

Objective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).

Cardiac activity. Additionally, 4-channel ECG signal with Texas Instruments ADS1299 will be used to collect data for calculating the periodic repolarization period (PRD).

Interventions & Apparatus

The Cold Pressor Test The CPT test will be used to induce tonic pain in phase 1.The CPT is a tonic pain stimulus where participants immerse their hand into 2 degrees Celcius cold water.

The Stroop task The Stroop task will be used as a mild, acute stressor.

Wearable device The EdaMove 4 device provided by Movisens GmbH consists of an EDA and activity sensor. It will be used to collect data during the entire experimental procedure including the CPT and Stroop task.

Texas Instruments ADS1299 amplifier Texas Instruments ADS1299 amplifier will be used to collect a 4-channel ECG signal to analyze the PRD during the tonic pain stimulation with the CPT.

Software Python, R and STATA will be used for statistical analyses.

Conditions

Healthy; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CPT only

Participants go through the cold pressor test.

Group Type: EXPERIMENTAL

Cold pressor test

Intervention Type: OTHER

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

CPT and Stroop

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

Group Type: EXPERIMENTAL

Stroop task

Intervention Type: 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).

Cold pressor test

Intervention Type: OTHER

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

Interventions

Stroop task

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).

Intervention Type: OTHER

Cold pressor test

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Danish
• Age over 18

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Kirstine Skov Benthien

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirstine Skov Benthien, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Hvidovre

Locations

Copenhagen University Hospital - Hvidovre

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kirstine S Benthien, PhD

Role: CONTACT

kirstine.skov.benthien.01@regionh.dk

+45 21 59 65 92 ext. 45

Faidra Papanikolaou, MSc, MEng

Role: CONTACT

faidra.papanikolaou@regionh.dk

Facility Contacts

Faidra Papanikolaou, MSc, MEng

Role: primary

faidra.papanikolaou@regionh.dk

Other Identifiers

H-24037808-Phase-1

Identifier Type: -

Identifier Source: org_study_id