PainNCT06663761
Correlation of Pain Intensity Measurements in Healthy Volunteers Exposed to Unpleasant Stimuli
A study testing Stimuli in people with Pain, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePoland
- Study dates
- 22 Jul 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiology (ASA) general condition assessment 1 or 2
- age 18 - 40 yrs
Who cannot join
- any arrhythmia,
- taking medications from the groups of beta-blockers, gabapentinoids, benzodiazepines, painkillers within the last 12 hours,
- chronic pain conditions,
- pregnancy,
- trypanophobia (fear of needles)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, 80-210
About this study
Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. There are many ways to measure pain, both through patient self-report (scales) and objective physiological indicators. However, there is no single, universal tool for measuring pain intensity that is simultaneously reliable, valid, and easy to use. Moreover, there are reports showing that not only the intensity of the unpleasant experience but also the nature of the stimulus can cause different levels of changes in the used indicators and scales. In this project, we will compare two devices used for pain monitoring based on physiological parameters: PainMonitor (Med-Storm, Oslo, Norway) and ANI Monitor (MetroDoloris, Loos, France). PainMonitor is a device that records skin conductance (SC) as an indicator of pain intensity. SC reflects the level of autonomic nervous system arousal. The device automatically analyzes these parameters and provides a numerical indicator of pain intensity/anesthesia level. The ANI Monitor is a device based on the analysis of parasympathetic nervous system activity through heart rate variability analysis. Based on this, the device also assesses the degree of pain intensity and presents it in numerical form. The aim of the project is to investigate the correlation between PainMonitor and ANI as tools for measuring pain intensity in situations where healthy volunteers are exposed to various unpleasant stimuli.
The study will involve approximately 100 healthy adult participants who will be exposed to three types of standardized stimuli: thermal (hot and cold), mechanical (pressure from a blood pressure cuff, pressure on a skin fold), chemical (spicy taste), and visual. Simultaneously, they will be monitored by PainMonitor, ANI, ECG, and peripheral perfusion index (using pulse oximetry). This data will then be compared and subjected to statistical analysis to determine if there is a relationship between the nature of the stimuli used and the objective and subjective indicators of pain intensity.
Read more
Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:
- NON-INVASIVE BLOOD PRESSURE MEASUREMENT: Non-invasive blood pressure measurement (NIBP) (single automatic blood pressure measurement using a Phillips IntelliVue Monitor).
- HEAT: A metal cube with a temperature of 45 degrees Celsius will be used for heat stimulation. The cube will be applied for 60 seconds to the inner side of the forearm of the participant's dominant hand. The appropriate temperature of the cube will be maintained by keeping it in a water bath.
- ALGOMETER: For mechanical stimulation, the researcher will apply pressure to the skin fold between the second and third fingers of the dominant hand using an algometer. The pressure will gradually increase from 0 to 250-300 kilo Pascal (kPa) and be maintained for 60 seconds.
- VISUAL STIMULUS: For visual stimulation, a video will be shown on a display in front of the participant, depicting a model having a short intravenous cannula inserted. Participants will be asked to imagine that the hand on the screen is their own.
- COLD: "Cold pressor test" - The participant's forearm will be immersed in water at a temperature of 2 degrees Celsius for 60 seconds or until discomfort causes the participant to withdraw their hand.
- SPICY TASTE: 0.5 ml of spicy sauce with a specified amount of Scoville units will be applied to the participant's tongue using a syringe.
- Conditions
- Pain
- Being tested
- Stimuli
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimuliBehavioural
Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:
- Non-invasive blood pressure measurement
- Heat
- Mechanical stimulation
- Visual stimulation
- Cold pressor test
- Spicy taste
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will be exposed to unpleasant stimuli, and their response will be determined. Receives: Behavioral: Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Monitor Measurements.
Skin conductance will be recorded using PainMonitor (Med-Storm, Oslo, Norway) - on the non-dominant hand.
Measured: Continuously throughout whole study - approximately 1.5 hours
Heart rate and its variability (HRV) - high frequencies
Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match high frequency band (0.15 to 0.4 Hz) will be recorded.
Measured: Continuously throughout whole study - approximately 1.5 hours
Heart rate and its variability (HRV) - low frequencies
Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match low frequency band (0.04 to 0.15 Hz) will be recorded.
Measured: Continuously throughout whole study - approximately 1.5 hours
The analgesia-nociception index (ANI)
The analgesia-nociception index (ANI) will be recorded using a dedicated device (MetroDoloris, Loos, France).
Measured: Continuously throughout whole study - approximately 1.5 hours
Perfusion index (PI)
Perfusion index (PI) will be recorded using the pulse oximeter of the Phillips IntelliVue monitor - index finger of the non-dominant hand.
Measured: Continuously throughout whole study - approximately 1.5 hours
Subjective discomfort/pain - NRS
Subjective discomfort/pain will be monitored using the Numerical Rating Scale (NRS, 0-10).
Measured: After each stimuli - approximately 1.5 hours
Subjective discomfort/pain - McGill Pain Questionnaire
Subjective discomfort/pain will be monitored using the McGill Pain Questionnaire (SF-MPQ).
Measured: After each stimuli - approximately 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start22 Jul 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radosław Owczuk, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663761
- Sponsor's protocol ID
- KB/259/2024
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2024
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Pain Intensity Measurements in Healthy Volunteers Exposed to Unpleasant Stimuli
- ClinicalTrials.gov ID
- NCT06663761
- Acronym / sponsor ID
- KB/259/2024
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Oct 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.
Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. There are many ways to measure pain, both through patient self-report (scales) and objective physiological indicators. However, there is no single, universal tool for measuring pain intensity that is simultaneously reliable, valid, and easy to use. Moreover, there are reports showing that not only the intensity of the unpleasant experience but also the nature of the stimulus can cause different levels of changes in the used indicators and scales. In this project, we will compare two devices used for pain monitoring based on physiological parameters: PainMonitor (Med-Storm, Oslo, Norway) and ANI Monitor (MetroDoloris, Loos, France). PainMonitor is a device that records skin conductance (SC) as an indicator of pain intensity. SC reflects the level of autonomic nervous system arousal. The device automatically analyzes these parameters and provides a numerical indicator of pain intensity/anesthesia level. The ANI Monitor is a device based on the analysis of parasympathetic nervous system activity through heart rate variability analysis. Based on this, the device also assesses the degree of pain intensity and presents it in numerical form. The aim of the project is to investigate the correlation between PainMonitor and ANI as tools for measuring pain intensity in situations where healthy volunteers are exposed to various unpleasant stimuli.
The study will involve approximately 100 healthy adult participants who will be exposed to three types of standardized stimuli: thermal (hot and cold), mechanical (pressure from a blood pressure cuff, pressure on a skin fold), chemical (spicy taste), and visual. Simultaneously, they will be monitored by PainMonitor, ANI, ECG, and peripheral perfusion index (using pulse oximetry). This data will then be compared and subjected to statistical analysis to determine if there is a relationship between the nature of the stimuli used and the objective and subjective indicators of pain intensity.
Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:
- NON-INVASIVE BLOOD PRESSURE MEASUREMENT: Non-invasive blood pressure measurement (NIBP) (single automatic blood pressure measurement using a Phillips IntelliVue Monitor).
- HEAT: A metal cube with a temperature of 45 degrees Celsius will be used for heat stimulation. The cube will be applied for 60 seconds to the inner side of the forearm of the participant's dominant hand. The appropriate temperature of the cube will be maintained by keeping it in a water bath.
- ALGOMETER: For mechanical stimulation, the researcher will apply pressure to the skin fold between the second and third fingers of the dominant hand using an algometer. The pressure will gradually increase from 0 to 250-300 kilo Pascal (kPa) and be maintained for 60 seconds.
- VISUAL STIMULUS: For visual stimulation, a video will be shown on a display in front of the participant, depicting a model having a short intravenous cannula inserted. Participants will be asked to imagine that the hand on the screen is their own.
- COLD: "Cold pressor test" - The participant's forearm will be immersed in water at a temperature of 2 degrees Celsius for 60 seconds or until discomfort causes the participant to withdraw their hand.
- SPICY TASTE: 0.5 ml of spicy sauce with a specified amount of Scoville units will be applied to the participant's tongue using a syringe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: StimuliParticipants will be exposed to unpleasant stimuli, and their response will be determined. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) general condition assessment 1 or 2
- age 18 - 40 yrs
Key exclusion criteria (5 listed)
- any arrhythmia,
- taking medications from the groups of beta-blockers, gabapentinoids, benzodiazepines, painkillers within the last 12 hours,
- chronic pain conditions,
- pregnancy,
- trypanophobia (fear of needles)
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 |
|---|---|---|
| StimuliStimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes: 1. Non-invasive blood pressure measurement 2. Heat 3. Mechanical stimulation 4. Visual stimulation 5. Cold pressor test 6. Spicy taste | Behavioural | Experimental group |
Primary outcome
Pain Monitor Measurements.
Time frame: Continuously throughout whole study - approximately 1.5 hours
Skin conductance will be recorded using PainMonitor (Med-Storm, Oslo, Norway) - on the non-dominant hand.
Heart rate and its variability (HRV) - high frequencies
Time frame: Continuously throughout whole study - approximately 1.5 hours
Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match high frequency band (0.15 to 0.4 Hz) will be recorded.
Heart rate and its variability (HRV) - low frequencies
Time frame: Continuously throughout whole study - approximately 1.5 hours
Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match low frequency band (0.04 to 0.15 Hz) will be recorded.
The analgesia-nociception index (ANI)
Time frame: Continuously throughout whole study - approximately 1.5 hours
The analgesia-nociception index (ANI) will be recorded using a dedicated device (MetroDoloris, Loos, France).
Perfusion index (PI)
Time frame: Continuously throughout whole study - approximately 1.5 hours
Perfusion index (PI) will be recorded using the pulse oximeter of the Phillips IntelliVue monitor - index finger of the non-dominant hand.
Subjective discomfort/pain - NRS
Time frame: After each stimuli - approximately 1.5 hours
Subjective discomfort/pain will be monitored using the Numerical Rating Scale (NRS, 0-10).
Subjective discomfort/pain - McGill Pain Questionnaire
Time frame: After each stimuli - approximately 1.5 hours
Subjective discomfort/pain will be monitored using the McGill Pain Questionnaire (SF-MPQ).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimuli in people with Pain, run by Medical University of Gdansk at 1 site in Poland.
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 5 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: finished, as of the sponsor's last update on 10 Jul 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Monitor Measurements. (time frame: Continuously throughout whole study - approximately 1.5 hours). The study lists 7 primary outcomes in all. 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 10 Jul 2026.