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Effect of TENS Application After Thoracic Surgery

Primary Purpose

Transcutaneous Electrical Nerve Stimulation, Procedural Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: be over 18 years old no chest tube not have a pacemaker or arrhythmia no history of pain, alcohol use or substance abuse no prior pre-operative TENS/opioid use no postoperative epidural analgesics no history of psychiatric illness no history of metastatic disease being conscious, able to speak no barriers to the application of TENS no postoperative complications and being I, II and III in the ASA classification of the American Society of Anesthesiology. Exclusion Criteria: having a history of epilepsy using analgesics at least 1 hour before chest tube removal.

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TENS group

Control group

Arm Description

TENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed.

TENS will not be applied to the control group

Outcomes

Primary Outcome Measures

Change in the pain level
Reducing the pain level of patients by applying TENS. Patients' pain scores before, during and after the procedure will be evaluated using the VAS.
Change in analgesic consumption
Reducing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 hour after the procedure will be learned by using the questionnaire.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2023
Last Updated
June 23, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05927168
Brief Title
Effect of TENS Application After Thoracic Surgery
Official Title
Effect of TENS Application After Thoracic Surgery on Pain Level and Analgesic Consumption During Breast Tube Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After thoracic surgery, a chest tube is inserted to evacuate the air and fluid formed in the pleural space and to provide hemodynamic stability. During chest tube placement, subcutaneous tissue layers, muscles and parietal pleura are passed through. This process is a trauma and the affected tissues show an inflammatory reaction to the trauma. The chest tube adheres to the tissue it comes into contact with and may experience mild, moderate and severe pain due to the separation of the adhesion due to pulling during removal. Chest tube removal is described as a severely painful procedure in studies. Analgesics are generally used in the treatment of acute pain during chest tube removal (Wei et al. 2022). However, pain guidelines and studies recommend the use of analgesics with non-pharmacological methods in order to minimize the pain experienced during chest tube removal and to provide adequate analgesia. One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). TENS, an electroanalgesia method, helps to control pain by providing skin stimulation through surface electrodes placed on the skin.While there are studies in the literature on the use of TENS in reducing the pain caused by chest tube removal after different surgical interventions, there are limited studies investigating the effect of TENS on the level of pain during chest tube removal and postoperative analgesic consumption after thoracic surgery. In this context, in this study, it is aimed to determine the effect of TENS application after thoracic surgery on pain level and analgesic requirement during chest tube removal.
Detailed Description
One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). Nurses play an important role in patient follow-up after surgery. It also has the responsibility to administer analgesics with the least side effects and the most effect. The New York Association of Nurses states that TENS is a complementary treatment method and its application strengthens the professional independence of nurses. However, as a result of our studies and observations, it is seen that there is no protocol for the use of TENS after thoracic surgery. TENS is applied together with physicians according to the nursing regulations in Turkey. Postoperative pain management requires team collaboration. Therefore, nurses should play a key role in pain management and use non-pharmacological methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcutaneous Electrical Nerve Stimulation, Procedural Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS group
Arm Type
Experimental
Arm Description
TENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
TENS will not be applied to the control group
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed. Patients' pain scores will be evaluated using the Numerical Pain Scale (SAS) just before the TENS procedure, while the chest tube is removed, and 5 minutes after the TENS application is finished.
Primary Outcome Measure Information:
Title
Change in the pain level
Description
Reducing the pain level of patients by applying TENS. Patients' pain scores before, during and after the procedure will be evaluated using the VAS.
Time Frame
1 hour
Title
Change in analgesic consumption
Description
Reducing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 hour after the procedure will be learned by using the questionnaire.
Time Frame
2 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be over 18 years old no chest tube not have a pacemaker or arrhythmia no history of pain, alcohol use or substance abuse no prior pre-operative TENS/opioid use no postoperative epidural analgesics no history of psychiatric illness no history of metastatic disease being conscious, able to speak no barriers to the application of TENS no postoperative complications and being I, II and III in the ASA classification of the American Society of Anesthesiology. Exclusion Criteria: having a history of epilepsy using analgesics at least 1 hour before chest tube removal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Açelya Türkmen
Phone
+90 05424383439
Email
acelyaturkmen2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Açelya Türkmen, PhD
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Acelya TURKMEN, PhD
Phone
+9005424383439
Email
acelyaturkmen2@gmail.com.tr
First Name & Middle Initial & Last Name & Degree
Sevilay ERDEN, PhD
Phone
+9005393231872
Email
sevilaygil@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of TENS Application After Thoracic Surgery

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