PainNCT01865344
Skin Conductance Fluctuations Per Sec and NRS to Monitor Pain
An observational study of Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and skin conductance responses per second at rest and in response to a painful stimulus. Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec to a standardized painful stimulus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Oct 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cardiac patients prior to, during, and after anesthesia for surgery. The proposed pilot study will be conducted at the Acute Clinic, Rikshospitalet - Oslo University hospital, Oslo, Norway.
Who may be able to join
- Age: Older than 18 years, patients scheduled for cardiac surgery.
- Patients admitted to the Cardiac Unit with cardiac disease.
- Patients able to verbally communicate pain level during or after the procedures.
- Pain medication following institutional standard care; only diazepam given before the painful procedure. During surgery, institutional standard care for sedation will be given.
Who cannot join
- Administration or anesthesia or analgesia other than diazepam prior to evaluation with the PainMonitor.
- Presence of any neurological disease affecting the peripheral nerves.
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Severe neuropathic disease
- Use of neostigmine before event 1, 2, and 3, see events below.
- Use of atropin
- Use of regional anesthesia at the extremity where the device electrodes are placed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Acute Clinic, Rikshospitalet - Oslo University hospital
Oslo, 0027
About this study
Official title: A Pilot Study for the PainMonitor During Standardized Painful Stimuli and no Stimuli to Calculate the Sensitivity and Specificity and Thereby the Accuracy of the Monitor
To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and skin conductance responses per second at rest and in response to a painful stimulus. Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec to a standardized painful stimulus. Furthermore, predictors of pain will be examined.
Read the detailed description
Cardiac surgery patients will be consented for participation in this trial. They will be asked about their pre-existing pain, anxiety about the needle-insertion and anxiety about the outcome of the operation, and employment status. This information will be obtained from self-reported schemas from the patients about presence/absence of pain and anxiety (the response options: yes/no) (1). The intensities of pain and anxiety will measured with NRS also ranging from 0 to 10 with one statement in each range: 0 no pain and 10 worst possible pain, and 0 no anxiety and 10 worst possible anxiety. The participants were requested to mark the point at the line that best agreed with how the pain and anxiety were experienced. The intensity of pain scored more than 3 on NRS was considered to be equal to moderate pain or more (1). Furthermore, patients in the Cardiac Surgery unit will be observed when undergoing pre-defined standardized painful stimuli as part of the standard of care treatment prior to and during surgery. The proposed study is structured using three events.
- Event 1: no stimuli, the period before placement of an arterial catheter when the patient has been administered diazepam, but is awake and calm. The registration will be for 1 min, 1 min before anticipated arterial line placement.
- Event 2: standardized painful stimulus, arterial catheter placement, with diazepam as premedication. The registration will be during arterial catheter placement.
- Event 3: no stimuli; patient is anesthetized before intubation. The registration will be for 1 min 1 min before anticipated intubation.
- There will also be one skin conductance response per sec registration for 1 min and the NRS score, one day postoperatively, when asking the patient about any side effects from the study.
During all defined events, the subject's skin conductance responses will be evaluated using the PainMonitor, and the subject will be asked to report pain using the 10 point NRS scale when awake. Before intubation when the patient is anesthetized, without stimuli, it is defined that the patient has no pain.
During these events, the number of skin conductance responses/sec will be analyzed in the defined time period, and this value will be used for statistical analyses. NRS scores will be obtained after the event and the value of the felt pain during the event will be asked for.
- Conditions
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart surgery | Pain monitoring at different time periods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance responses per sec and NRS before and during painful procedures
- No significant adverse events related to use of the Pain Monitor device
- Increase in skin conductance responses per sec and NRS after administration of painful stimulus compared to the non-painful situations.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
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 Oslo University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Jan F Bugge, MD.PhD, Principal investigator, Head of the Anesthesia Thorax department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865344
- Sponsor's protocol ID
- REK sør-øst 2013/196
- Status last verified
- Dec 2013
- First submitted
- 27 May 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the PainMonitor During Standardized Painful Stimuli and no Stimuli to Calculate the Sensitivity and Specificity and Thereby the Accuracy of the Monitor
- ClinicalTrials.gov ID
- NCT01865344
- Acronym / sponsor ID
- REK sør-øst 2013/196
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 May 2013 (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.
To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and skin conductance responses per second at rest and in response to a painful stimulus. Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec to a standardized painful stimulus. Furthermore, predictors of pain will be examined.
Detailed description
Cardiac surgery patients will be consented for participation in this trial. They will be asked about their pre-existing pain, anxiety about the needle-insertion and anxiety about the outcome of the operation, and employment status. This information will be obtained from self-reported schemas from the patients about presence/absence of pain and anxiety (the response options: yes/no) (1). The intensities of pain and anxiety will measured with NRS also ranging from 0 to 10 with one statement in each range: 0 no pain and 10 worst possible pain, and 0 no anxiety and 10 worst possible anxiety. The participants were requested to mark the point at the line that best agreed with how the pain and anxiety were experienced. The intensity of pain scored more than 3 on NRS was considered to be equal to moderate pain or more (1). Furthermore, patients in the Cardiac Surgery unit will be observed when undergoing pre-defined standardized painful stimuli as part of the standard of care treatment prior to and during surgery. The proposed study is structured using three events.
- Event 1: no stimuli, the period before placement of an arterial catheter when the patient has been administered diazepam, but is awake and calm. The registration will be for 1 min, 1 min before anticipated arterial line placement.
- Event 2: standardized painful stimulus, arterial catheter placement, with diazepam as premedication. The registration will be during arterial catheter placement.
- Event 3: no stimuli; patient is anesthetized before intubation. The registration will be for 1 min 1 min before anticipated intubation.
- There will also be one skin conductance response per sec registration for 1 min and the NRS score, one day postoperatively, when asking the patient about any side effects from the study.
During all defined events, the subject's skin conductance responses will be evaluated using the PainMonitor, and the subject will be asked to report pain using the 10 point NRS scale when awake. Before intubation when the patient is anesthetized, without stimuli, it is defined that the patient has no pain.
During these events, the number of skin conductance responses/sec will be analyzed in the defined time period, and this value will be used for statistical analyses. NRS scores will be obtained after the event and the value of the felt pain during the event will be asked for.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart surgery | – | –Pain monitoring at different time periods |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cardiac patients prior to, during, and after anesthesia for surgery. The proposed pilot study will be conducted at the Acute Clinic, Rikshospitalet - Oslo University hospital, Oslo, Norway.
Key inclusion criteria (4 listed)
- Age: Older than 18 years, patients scheduled for cardiac surgery.
- Patients admitted to the Cardiac Unit with cardiac disease.
- Patients able to verbally communicate pain level during or after the procedures.
- Pain medication following institutional standard care; only diazepam given before the painful procedure. During surgery, institutional standard care for sedation will be given.
Key exclusion criteria (8 listed)
- Administration or anesthesia or analgesia other than diazepam prior to evaluation with the PainMonitor.
- Presence of any neurological disease affecting the peripheral nerves.
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Severe neuropathic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin conductance responses per sec and NRS before and during painful procedures
Time frame: 8 months
* No significant adverse events related to use of the Pain Monitor device * Increase in skin conductance responses per sec and NRS after administration of painful stimulus compared to the non-painful situations.
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 4 Dec 2013.
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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.
Jan F Bugge, MD.PhD principal investigator
Head of the Anesthesia Thorax department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Oslo University Hospital at 1 site in Norway.
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 8 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 4 Dec 2013. 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 Norway. 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?
Skin conductance responses per sec and NRS before and during painful procedures (time frame: 8 months). 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 4 Dec 2013.