HealthyDEEP 1NCT06678217
Detection of Electrodermal Activity in Pain 1
A study testing Stroop task and Cold pressor test in people with Healthy and Acute Pain, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Acute Pain
- What is being tested?
- Stroop task and Cold pressor test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Danish
- Age over 18
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Electrodermal Activity in Pain (DEEP)
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:
Read more
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.
Read the 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
- Being tested
- Stroop task, Cold pressor test
- Keywords
- pain, electrodermal activity, pain detection, pain prediction, galvanic skin response, wearable, pain monitoring
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroop taskOther
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 testOther
The participant lowers their hand in icy water to induce temporary tonic pain
| Study group | Role | What they receive |
|---|---|---|
| CPT only | Experimental | Participants go through the cold pressor test. Receives: Other: Cold pressor test |
| CPT and Stroop | Experimental | Participants go through the Stroop task before the cold pressor test. Receives: Other: Stroop task; Other: Cold pressor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: while participants have their wrist immersed in cold water for the Cold Pressor Test, for maximum 3 minutes.
Secondary outcomes (5)
Skin conductance level
The average skin conductance value (μS) for periods of 10 seconds.
Measured: while participants wear the device throughout testing, which lasts up to fifteen minutes.
Number of Skin Conductance Fluctuations
Peaks with minimum amplitudes of 0.02 μS and a slope rate < 2 μS/s, in 10 second intervals.
Measured: while participants wear the device throughout testing, which lasts up to fifteen minutes.
Cold pressor endurance time
Maximum time of immersion in cold water.
Measured: while participants have their wrist immersed in cold water for the Cold Pressor Test
The Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) will be used to screen participants as symptoms of depression in order to control during the statistical analysis.
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), providing a 0 to 27 severity score.
Measured: administered the day of testing
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), asking participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain
Higher scores indicate higher levels of pain catastrophizing and the total score range varies from 0 to 52.
Measured: administered the day of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Kirstine Skov Benthien, Copenhagen University Hospital, Hvidovre
- Investigators
- Kirstine Skov Benthien, PhD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678217
- Sponsor's protocol ID
- H-24037808-Phase-1
- Acronym
- DEEP 1
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Electrodermal Activity in Pain (DEEP)
- ClinicalTrials.gov ID
- NCT06678217
- Acronym / sponsor ID
- DEEP 1 / H-24037808-Phase-1
- Conditions
- Healthy, Acute Pain
- Keywords
- pain, electrodermal activity, pain detection, pain prediction, galvanic skin response, wearable, pain monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPT only | Experimental | Other: Cold pressor testParticipants go through the cold pressor test. |
| CPT and Stroop | Experimental | Other: Stroop task, Other: Cold pressor testParticipants go through the Stroop task before the cold pressor test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Danish
- Age over 18
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroop taskThe 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). | Other | CPT and Stroop |
| Cold pressor testThe participant lowers their hand in icy water to induce temporary tonic pain | Other | CPT and Stroop, CPT only |
Primary outcome
Pain intensity
Time frame: 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.
5 secondary outcomes
Skin conductance level
Time frame: while participants wear the device throughout testing, which lasts up to fifteen minutes.
Number of Skin Conductance Fluctuations
Time frame: while participants wear the device throughout testing, which lasts up to fifteen minutes.
Cold pressor endurance time
Time frame: while participants have their wrist immersed in cold water for the Cold Pressor Test
The Patient Health Questionnaire (PHQ-9)
Time frame: administered the day of testing
Pain Catastrophizing
Time frame: administered the day of testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstine Skov Benthien, PhD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroop task and Cold pressor test in people with Healthy and Acute Pain, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: while participants have their wrist immersed in cold water for the Cold Pressor Test, for maximum 3 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.