PainNCT02276703
Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
An observational study of Pain, run by Milton S. Hershey Medical Center at 2 sites in 2 countries.
Trial summary
Pain in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pain
- What is being tested?
- Skin Conductance Monitor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to Jun 2017
- Phase
- Observational
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Intensive Care Unit (ICU) patients between the ages of 18-89 years (inclusive), that are scheduled to receive a painful procedure. We are requesting a total population of 120 to allow for withdrawals
Who may be able to join
- Patients between the ages of 18-89 years (inclusive), in an adult ICU
- Patients admitted to the ICU who are able to communicate their pain and anxiety using a VAS
- Patients must be cooperative and not agitated.
- Planned to have a potentially painful procedure
Who cannot join
- Diagnosed neuropathic disease
- Use of neostigmine within the past 3 hours
- Use of regional anesthesia at the extremity where the device electrodes are placed
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Pain in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales.
When a patient is unable to communicate, a method that would allow the caregiver to continuously monitor patients' pain and alert the provider that the patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing changes in skin conductance that can be used in patients who are unable to provide a subjective pain score. This study will compare the relationship between the measurements taken by the PainMonitor and pain scores given by communicative patients to evaluate the safety and efficacy of this monitor during planned, routine procedures.
Read the detailed description
Although pain must be assessed to be treated, it has been challenging to obtain consistent, objective, and quantifiable measurements. The best methods currently available are subjective scales communicated by the patient such as standardized sentences, visual analog scales (VAS), or plain numeric scales.
When a patient is unable to communicate, methods used to monitor pain are inadequate. A device that provides an objective assessment of pain in these patients would alert the patient's caregivers that the patient may be in pain and analgesic treatment is indicated.
Various methods (Evans et al, 2013; Kantor, 2014; Isnardon, 2013) have been proposed to monitor patients' reactions to nociceptive stimulation such as:
- changes in heart rate or blood pressure
- changes in microcirculation
- pupillometry
- EEG
- Auditory or somatosensory evoked potentials
All of these methods have been found lacking, mostly due to a lack of specificity for pain. Pupillometry is not suitable for long periods of measurement and is sensitive to concomitant treatment (e.g. opioids).
Galvanometry has the potential to provide specific information related to pain in patients who are unable to communicate.
Since sweat glands are the only organs controlled solely by the sympathetic nervous system, there is a reasonable chance that the use of galvanometry can provide a reliable means of assessing pain. There are numerous papers on this topic; searching in PUBmed on the key words "pain" and "skin conductance" results in more than 250 papers (selected references are included in the list below). The PainMonitor system uses galvanometry to monitor changes in skin conductance responses per sec mirroring the number of bursts in the skin sympathetic nerves. This creates a warning for caregivers to assess the potential that the patient is in pain.
- Conditions
- Pain
- Being tested
- Skin Conductance Monitor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Conductance MonitorDevice
Also called Algesimeter
monitors skin conductance values
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity with a confidence interval
Sensitivity and specificity with a confidence interval > 80 % when skin conductance responses per sec are > 0.13 and VAS is equal to or greater than 30 mm. This end point will be reached by 100 patients with at least 10 discrete measurements for each patient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2017
- Study completionJun 2017
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 Milton S. Hershey Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Med-Storm Innovation, Hopital Foch
- Responsible party
- Principal investigator, Elizabeth H. Sinz, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276703
- Sponsor's protocol ID
- STUDY00000725
- Status last verified
- Sep 2017
- First submitted
- 24 Oct 2014
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
- ClinicalTrials.gov ID
- NCT02276703
- Acronym / sponsor ID
- STUDY00000725
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Med-Storm Innovation, Hopital Foch
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Oct 2014 (estimated)
- 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 in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales.
When a patient is unable to communicate, a method that would allow the caregiver to continuously monitor patients' pain and alert the provider that the patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing changes in skin conductance that can be used in patients who are unable to provide a subjective pain score. This study will compare the relationship between the measurements taken by the PainMonitor and pain scores given by communicative patients to evaluate the safety and efficacy of this monitor during planned, routine procedures.
Detailed description
Although pain must be assessed to be treated, it has been challenging to obtain consistent, objective, and quantifiable measurements. The best methods currently available are subjective scales communicated by the patient such as standardized sentences, visual analog scales (VAS), or plain numeric scales.
When a patient is unable to communicate, methods used to monitor pain are inadequate. A device that provides an objective assessment of pain in these patients would alert the patient's caregivers that the patient may be in pain and analgesic treatment is indicated.
Various methods (Evans et al, 2013; Kantor, 2014; Isnardon, 2013) have been proposed to monitor patients' reactions to nociceptive stimulation such as:
- changes in heart rate or blood pressure
- changes in microcirculation
- pupillometry
- EEG
- Auditory or somatosensory evoked potentials
All of these methods have been found lacking, mostly due to a lack of specificity for pain. Pupillometry is not suitable for long periods of measurement and is sensitive to concomitant treatment (e.g. opioids).
Galvanometry has the potential to provide specific information related to pain in patients who are unable to communicate.
Since sweat glands are the only organs controlled solely by the sympathetic nervous system, there is a reasonable chance that the use of galvanometry can provide a reliable means of assessing pain. There are numerous papers on this topic; searching in PUBmed on the key words "pain" and "skin conductance" results in more than 250 papers (selected references are included in the list below). The PainMonitor system uses galvanometry to monitor changes in skin conductance responses per sec mirroring the number of bursts in the skin sympathetic nerves. This creates a warning for caregivers to assess the potential that the patient is in pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Intensive Care Unit (ICU) patients between the ages of 18-89 years (inclusive), that are scheduled to receive a painful procedure. We are requesting a total population of 120 to allow for withdrawals
Key inclusion criteria (4 listed)
- Patients between the ages of 18-89 years (inclusive), in an adult ICU
- Patients admitted to the ICU who are able to communicate their pain and anxiety using a VAS
- Patients must be cooperative and not agitated.
- Planned to have a potentially painful procedure
Key exclusion criteria (3 listed)
- Diagnosed neuropathic disease
- Use of neostigmine within the past 3 hours
- Use of regional anesthesia at the extremity where the device electrodes are placed
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 |
|---|---|---|
| Skin Conductance MonitorAlso: Algesimetermonitors skin conductance values | Device | – |
Primary outcome
Sensitivity and specificity with a confidence interval
Time frame: 1 year
Sensitivity and specificity with a confidence interval > 80 % when skin conductance responses per sec are > 0.13 and VAS is equal to or greater than 30 mm. This end point will be reached by 100 patients with at least 10 discrete measurements for each patient.
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 15 Sep 2017.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Milton S. Hershey Medical Center at 2 sites in 2 countries.
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 4 inclusion and 3 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. 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?
Sensitivity and specificity with a confidence interval (time frame: 1 year). 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 15 Sep 2017.