Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy

May 5, 2017 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy

The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60100
        • Gaziosmanpasa University Medical School

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients aged between18-65 undergoing elective abdominal hysterectomy
  • ASA (American Society of Anesthesiologist) I,II physical status

Exclusion Criteria:

  • Not agreement with the study,Dermatological lesion affecting the electrode place,
  • Chronic or preprocedural use of opioids, steroids or psychoactive drugs,
  • Allergy to drugs used during trials,
  • Previous experience in TENS,
  • Kidney, liver, neurological or cardiovascular system disease
  • Body mass index>40

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS
TENS treatment will be apply with 30 minutes sessions seven times per day at the intensity between 9-15 milliamps (mA) which will be adjusted depending on the sensitivity of each individual patient.
Device: TENS
Transcutaneous Electrical Nerve Stimulation will be apply
Other Names:
  • Transcutaneous Electrical Nerve Stimulation
Sham Comparator: Control
Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse.
Device: TENS
Transcutaneous Electrical Nerve Stimulation will be apply
Other Names:
  • Transcutaneous Electrical Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery
Time Frame: At twenty-four hours after surgery
QoR-40 (Quality of Recovery 40) form will be used for evaluation
At twenty-four hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: During 24 hours after surgery
Dynamic and static pain will be evaluated by visual analog scale(VAS)
During 24 hours after surgery
Analgesic Consumption
Time Frame: During 24 hours after surgery
Total consumption of analgesic will be recorded
During 24 hours after surgery
Postoperative Nausea and Vomiting
Time Frame: During 24 hours after surgery
Nausea and Vomiting scores will be recorded
During 24 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: During 24 hours after surgery
The number of adverse events will be recorded
During 24 hours after surgery

Collaborators and Investigators

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

Sponsor

Tokat Gaziosmanpasa University

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 (Actual)

March 31, 2016

Primary Completion (Actual)

May 5, 2017

Study Completion (Actual)

May 5, 2017

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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