Clinical trial NCT06678217: Detection of Electrodermal Activity in Pain 1
Official title: Detection of Electrodermal Activity in Pain (DEEP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Acute 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: 2024-11-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: while participants have their wrist immersed in cold water for the Cold Pressor Test, for maximum 3 minutes.
Secondary outcomes:
measure: Skin conductance level
timeFrame: while participants wear the device throughout testing, which lasts up to fifteen minutes.
measure: Number of Skin Conductance Fluctuations
timeFrame: while participants wear the device throughout testing, which lasts up to fifteen minutes.
measure: Cold pressor endurance time
timeFrame: while participants have their wrist immersed in cold water for the Cold Pressor Test
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: administered the day of testing
measure: Pain Catastrophizing
timeFrame: administered the day of testing
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital - Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Kirstine Skov Benthien, PhD
role: PRINCIPAL_INVESTIGATOR
References: