Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy

NCT ID: NCT03072888

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

Transcutaneous Electrical Nerve Stimulation will be apply

Control

Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse.

Group Type SHAM_COMPARATOR

TENS

Intervention Type DEVICE

Transcutaneous Electrical Nerve Stimulation will be apply

Interventions

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TENS

Transcutaneous Electrical Nerve Stimulation will be apply

Intervention Type DEVICE

Other Intervention Names

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Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Karaman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziosmanpasa University Medical School

Tokat Province, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TENS

Identifier Type: -

Identifier Source: org_study_id

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