NCT03072888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

February 20, 2017

Last Update Submit

May 5, 2017

Conditions

Pain, Acute

Keywords

acute painTranscutaneous Electric Nerve StimulationAnesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery

    QoR-40 (Quality of Recovery 40) form will be used for evaluation

    At twenty-four hours after surgery

Secondary Outcomes (3)

  • Pain

    During 24 hours after surgery

  • Analgesic Consumption

    During 24 hours after surgery

  • Postoperative Nausea and Vomiting

    During 24 hours after surgery

Other Outcomes (1)

  • Adverse events

    During 24 hours after surgery

Study Arms (2)

TENS

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Device: TENS

Interventions

TENSDEVICE

Transcutaneous Electrical Nerve Stimulation will be apply

Also known as: Transcutaneous Electrical Nerve Stimulation
ControlTENS

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Medical School

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 7, 2017

Study Start

March 31, 2016

Primary Completion

May 5, 2017

Study Completion

May 5, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)