Cannulation PainNCT01607463
The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation
A study testing Transcutaneous electrical nerve stimulation (Empi, USA) in people with Cannulation Pain, run by Kyungpook National University Hospital.
Trial summary
The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cannulation Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation (Empi, USA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- outpatients who underwent plastic surgery
Who cannot join
- concomitant sedative or analgesic medication,
- neurological disease.
- all patients with potentially dangerous internal diseases (American Society of Anesthesiologists' physical status > 3).
About this study
The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein.
Read the detailed description
One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. During venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded
- Conditions
- Cannulation Pain
- Being tested
- Transcutaneous electrical nerve stimulation (Empi, USA)
- Keywords
- pain, transcutaneous electrical nerve stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (Empi, USA)Procedure or surgery
In the active TENS group, TENS at 80 pulsed currents per second (PPS) with a pulse duration of 200 μs were delivered for 20 minutes. Current amplitude was slowly increased until a level was reached that participants reported was the maximum level they could tolerate below pain threshold without noticeable muscle contraction and maintained this intensity.
Transcutaneous electrical nerve stimulation (Empi, USA)Procedure or surgery
In the placebo group the TENS device had no current output although the power "on" indicator light remained active.
| Study group | Role | What they receive |
|---|---|---|
| active TENS group | Experimental | Two electrodes were attached to the radial side of dominant forearm. In the active TENS group, TENS was delivered via two electrodes on the venous cannulation site Receives: Procedure: Transcutaneous electrical nerve stimulation (Empi, USA) |
| Placebo group | Placebo comparator | Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active. Receives: Procedure: Transcutaneous electrical nerve stimulation (Empi, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation
One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. One minute after venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded
Measured: one minute after cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannulation PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Dr, Principal investigator, 2. Anesthesiology and Pain Medicine, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607463
- Sponsor's protocol ID
- KNUH 2012-04-014-001
- Status last verified
- May 2012
- First submitted
- 22 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim S, Park K, Son B, Jeon Y. The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation. Curr Ther Res Clin Exp. 2012 Sep;73(4-5):134-9. doi: 10.1016/j.curtheres.2012.05.001.
PubMed 24653515
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation
- ClinicalTrials.gov ID
- NCT01607463
- Acronym / sponsor ID
- KNUH 2012-04-014-001
- Conditions
- Cannulation Pain
- Keywords
- pain, transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 May 2012 (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.
The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein.
Detailed description
One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. During venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active TENS group | Experimental | Procedure: Transcutaneous electrical nerve stimulation (Empi, USA)Two electrodes were attached to the radial side of dominant forearm. In the active TENS group, TENS was delivered via two electrodes on the venous cannulation site |
| Placebo group | Placebo comparator | Procedure: Transcutaneous electrical nerve stimulation (Empi, USA)Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients who underwent plastic surgery
Key exclusion criteria (3 listed)
- concomitant sedative or analgesic medication,
- neurological disease.
- all patients with potentially dangerous internal diseases (American Society of Anesthesiologists' physical status > 3).
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (Empi, USA)In the active TENS group, TENS at 80 pulsed currents per second (PPS) with a pulse duration of 200 μs were delivered for 20 minutes. Current amplitude was slowly increased until a level was reached that participants reported was the maximum level they could tolerate below pain threshold without noticeable muscle contraction and maintained this intensity. | Procedure or surgery | active TENS group |
| Transcutaneous electrical nerve stimulation (Empi, USA)In the placebo group the TENS device had no current output although the power "on" indicator light remained active. | Procedure or surgery | Placebo group |
Primary outcome
The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation
Time frame: one minute after cannulation
One hundred patients were allocated randomly to two groups: In the active TENS group TENS was delivered via two electrodes on the venous cannulation site (radial side of the wrist of dominant forearm) 20 min prior to venous cannulation and control group received placebo (no current) TENS. Venous cannulation with a 22 gage cannula was performed. One minute after venous cannulation the pain intensity (0 = no pain, 10 = worst pain imaginable) was measured. Any side effects during study periods were recorded
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 30 May 2012.
- Derived from this study: PubMed 24653515Kim S, Park K, Son B, Jeon Y. The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation. Curr Ther Res Clin Exp. 2012 Sep;73(4-5):134-9. doi: 10.1016/j.curtheres.2012.05.001.
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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.
Younghoon Jeon, Dr principal investigator
2. Anesthesiology and Pain Medicine, Kyungpook National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (Empi, USA) in people with Cannulation Pain, run by Kyungpook National University Hospital.
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 1 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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The effect of transcutaneous electrical nerve stimulation on pain during venous cannulation (time frame: one minute after cannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607463, which also lists 1 linked publication.
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 30 May 2012.