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Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study (TENS)

Primary Purpose

Cholecystitis; Gallstone, Cholecystolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental group (Transcutaneous Electrical Nerve Stimulation)
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis; Gallstone focused on measuring Pain, Cholecystectomy, Nurse, TENS

Eligibility Criteria

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

Inclusion Criteria: Over 18 years old, Without pacemaker and arrhythmia, No previous history of chronic pain, alcohol or drug addiction, Not using TENS/opioids before surgery, Epidural analgesia is not applied in the postoperative period, without cognitive impairment, No thoracic incision other than cholecystectomy, Having at least 1 drain No metastatic disease No need for mechanical ventilation As a result of the evaluation by the physician, there is no objection to the application of TENS, Who agree to participate in the study, No postoperative complications Patients with American Society of Anesthesiology (ASA) evaluation I, II, III will be included in the sample group. Exclusion Criteria: refuse to participate in the study

Sites / Locations

  • Adana City Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group ( TENS will be applied )

Control Group ( TENS will not be applied )

Arm Description

After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity.

Application of the control group: TENS will not be applied to this group.

Outcomes

Primary Outcome Measures

The Numerical Rating Scale (NRS)
The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.

Secondary Outcome Measures

APS-POQ-R - American Pain Society Patient Outcome
American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.

Full Information

First Posted
July 19, 2023
Last Updated
July 19, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05962853
Brief Title
Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
Acronym
TENS
Official Title
Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (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
The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy.
Detailed Description
Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic cholecystectomy. The most common complication after laparoscopic cholecystectomy is pain. Pain appears as incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal wall as a result of intra-abdominal intervention are seen. After laparoscopic cholecystectomy, the effect of general anesthesia and the proximity of the incision area to the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation, increased intra-abdominal pressure, stretching of the peritoneum, and consequently the tension in the muscle fibers in the diaphragm can cause pain. Inability to control pain can lead to many undesirable conditions in the patient, such as reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This situation is also associated with increased hospital stay and financial burdens.In order to provide effective pain control, the combined use of pharmacological and non-pharmacological methods is important.Non-pharmacological methods are easy to learn, safe, have no definite contraindications, and provide pain management with non-drug applications. In a meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort and no serious side effects were observed. Studies have shown that TENS application reduces postoperative pain level and analgesia consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be associated with a decrease in postoperative pain severity and complaints of nausea and vomiting. It is seen that there are not enough resources in the literature regarding the application of TENS after laparoscopic cholecystectomy. The aim of this study is to evaluate the effect of TENS on patient outcomes after laparoscopic cholecystectomy. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis; Gallstone, Cholecystolithiasis
Keywords
Pain, Cholecystectomy, Nurse, TENS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient. Application of the control group: TENS will not be applied to this group
Masking
ParticipantOutcomes Assessor
Masking Description
Application will be made by the researcher and the outcome will be assessements will be performed by a investigator who is blinded to group allocation
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group ( TENS will be applied )
Arm Type
Experimental
Arm Description
After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity.
Arm Title
Control Group ( TENS will not be applied )
Arm Type
No Intervention
Arm Description
Application of the control group: TENS will not be applied to this group.
Intervention Type
Other
Intervention Name(s)
Experimental group (Transcutaneous Electrical Nerve Stimulation)
Intervention Description
The application will be applied at 8 hour intervals in the first 24 hours after the surgery.
Primary Outcome Measure Information:
Title
The Numerical Rating Scale (NRS)
Description
The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
APS-POQ-R - American Pain Society Patient Outcome
Description
American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years old, Without pacemaker and arrhythmia, No previous history of chronic pain, alcohol or drug addiction, Not using TENS/opioids before surgery, Epidural analgesia is not applied in the postoperative period, without cognitive impairment, No thoracic incision other than cholecystectomy, Having at least 1 drain No metastatic disease No need for mechanical ventilation As a result of the evaluation by the physician, there is no objection to the application of TENS, Who agree to participate in the study, No postoperative complications Patients with American Society of Anesthesiology (ASA) evaluation I, II, III will be included in the sample group. Exclusion Criteria: refuse to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cansel Bozer
Phone
+905434332624
Email
cansel9815@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ceylan Kişial
Phone
+905068010561
Email
cylnksl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cansel Bozer
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adana City Training and Research Hospital
City
Adana
State/Province
Yüreğir / Adana
ZIP/Postal Code
01220
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cansel Bozer

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study

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