Back to resultsEffects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
Primary Purpose
Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring acute pain, Transcutaneous Electric Nerve Stimulation, Anesthesia Recovery Period
Eligibility Criteria
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
Sites / Locations
- Gaziosmanpasa University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TENS
Control
Arm Description
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.
Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse.
Outcomes
Primary Outcome Measures
Quality of Recovery
QoR-40 (Quality of Recovery 40) form will be used for evaluation
Secondary Outcome Measures
Pain
Dynamic and static pain will be evaluated by visual analog scale(VAS)
Analgesic Consumption
Total consumption of analgesic will be recorded
Postoperative Nausea and Vomiting
Nausea and Vomiting scores will be recorded
Full Information
NCT ID
NCT03072888
First Posted
February 20, 2017
Last Updated
May 5, 2017
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT03072888
Brief Title
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
Official Title
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
acute pain, Transcutaneous Electric Nerve Stimulation, Anesthesia Recovery Period
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
Transcutaneous Electrical Nerve Stimulation will be apply
Primary Outcome Measure Information:
Title
Quality of Recovery
Description
QoR-40 (Quality of Recovery 40) form will be used for evaluation
Time Frame
At twenty-four hours after surgery
Secondary Outcome Measure Information:
Title
Pain
Description
Dynamic and static pain will be evaluated by visual analog scale(VAS)
Time Frame
During 24 hours after surgery
Title
Analgesic Consumption
Description
Total consumption of analgesic will be recorded
Time Frame
During 24 hours after surgery
Title
Postoperative Nausea and Vomiting
Description
Nausea and Vomiting scores will be recorded
Time Frame
During 24 hours after surgery
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
The number of adverse events will be recorded
Time Frame
During 24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gaziosmanpasa University Medical School
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
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