- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072888
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
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
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Tokat, Turkey, 60100
- Gaziosmanpasa University Medical School
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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.
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Transcutaneous Electrical Nerve Stimulation will be apply
Other Names:
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Sham Comparator: Control
Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse.
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Transcutaneous Electrical Nerve Stimulation will be apply
Other Names:
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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
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QoR-40 (Quality of Recovery 40) form will be used for evaluation
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At twenty-four hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: During 24 hours after surgery
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Dynamic and static pain will be evaluated by visual analog scale(VAS)
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During 24 hours after surgery
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Analgesic Consumption
Time Frame: During 24 hours after surgery
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Total consumption of analgesic will be recorded
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During 24 hours after surgery
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Postoperative Nausea and Vomiting
Time Frame: During 24 hours after surgery
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Nausea and Vomiting scores will be recorded
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During 24 hours after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: During 24 hours after surgery
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The number of adverse events will be recorded
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During 24 hours after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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