The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Venous Cannulation

May 24, 2012 updated by: Younghoon Jeon, Kyungpook National University Hospital
The purpose of this study was to investigate whether transcutaneous electrical nerve stimulation (TENS) could reduce pain during cannulation of vein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients who underwent plastic surgery

Exclusion Criteria:

  • concomitant sedative or analgesic medication,
  • neurological disease.
  • all patients with potentially dangerous internal diseases (American Society of Anesthesiologists' physical status > 3).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active TENS group
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
Procedure: 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: 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.
Placebo Comparator: Placebo group
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.
Procedure: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one minute after cannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Younghoon Jeon, Dr, 2. Anesthesiology and Pain Medicine, Kyungpook National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KNUH 2012-04-014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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