Detection of Electrodermal Activity in Pain 1

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Cold pressor test: The participant lowers their hand in icy water to induce temporary tonic pain

Study 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.

Eligibility

Primary outcome measure(s)

• Pain intensity — while participants have their wrist immersed in cold water for the Cold Pressor Test, for maximum 3 minutes.
  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.

Trial sites (1)

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