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The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) Application on Patients' Undergoing Hip Replacement

Primary Purpose

Hip Fractures, Pain, Postoperative, Analgesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
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 Hip Fractures focused on measuring Hip Replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Analgesia

Eligibility Criteria

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

Inclusion Criteria: be over 18 years old hip replacement insertion not have a pacemaker or arrhythmia no history of pain, alcohol use or substance abuse no history of pain, alcohol use or substance abuse no history of pain, alcohol use or substance abuse 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 being I, II and III in the ASA classification of the American Society of Anesthesiology, agreeing to participate in the study. Exclusion Criteria: having a history of epilepsy Using analgesics at least 1 hour before TENS is applied the presence of a wound in the area where the electrode will be placed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TENS group

    Control group

    Arm Description

    60 minutes of TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher. After the procedure, the amount of analgesic consumed by the experimental group in the first hour will be questioned and recorded.

    The routine treatment and care of the control group will not be interfered with.

    Outcomes

    Primary Outcome Measures

    Change in the pain level using the VAS.
    Reducing the pain level of patients undergoing hip replacement by applying TENS. A value of 0 on the scale means that the patient does not experience pain, and a value of 10 means that he experiences pain at the most severe level
    Change in analgesic consumption
    Changing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 days after the surgery will be learned by using the questionnaire.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 3, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Cukurova University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05939804
    Brief Title
    The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) Application on Patients' Undergoing Hip Replacement
    Official Title
    The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) Application on Patients' Pain Level and Analgesic Use in Patients Undergoing Hip Replacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 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 surgical treatment of an individual with osteoarthritis and hip fracture is provided by hip replacement surgery. While restructuring the joint surfaces with surgery, it is aimed to provide both hip joint movements and to treat pain. Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she/ he is with the patient for 24 hours. When the literature is examined, it is seen that the number of studies showing the effectiveness of TENS application in patients who underwent hip prosthesis, where studies were conducted with patients with knee gonarthrosis, is limited. In this direction, the aim of the study is to examine the effect of TENS application on patients' pain level and analgesic use in patients undergoing hip replacement.
    Detailed Description
    Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. Postoperative pain can be treated with narcotics, which is usually accompanied by adverse side effects such as nausea, vomiting, delirium, constipation and gastrointestinal dysfunction. In general, narcotic use should be limited, especially in the elderly, due to the higher incidence of these side effects in this population. However, poor pain management in the elderly not only hinders rehabilitation, but may also lead to other adverse consequences such as tachycardia, increased myocardial oxygen demand, cardiac ischemia and higher risk of post-operative delirium. Therefore, it is recommended to use non-pharmacological methods as well as pharmacological methods to manage postoperative pain. In the TENS technique, which is one of the non-pharmacological methods used in pain management, a controlled and low-voltage electric current is applied to the nervous system through the skin, and it is seen that the method is used as an effective and non-invasive treatment option in many painful conditions such as neuropathic pain, pain due to osteoarthritis, and post-operative pain. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she is with the patient for 24 hours. Considering the nursing studies conducted abroad on the application of TENS, it is seen that the nurses apply TENS as a non-pharmacological method in the treatment of pain and train the patients on the application of TENS at home.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fractures, Pain, Postoperative, Analgesia
    Keywords
    Hip Replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Analgesia

    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
    60 minutes of TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher. After the procedure, the amount of analgesic consumed by the experimental group in the first hour will be questioned and recorded.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The routine treatment and care of the control group will not be interfered with.
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Intervention Description
    TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher.
    Primary Outcome Measure Information:
    Title
    Change in the pain level using the VAS.
    Description
    Reducing the pain level of patients undergoing hip replacement by applying TENS. A value of 0 on the scale means that the patient does not experience pain, and a value of 10 means that he experiences pain at the most severe level
    Time Frame
    48 hour
    Title
    Change in analgesic consumption
    Description
    Changing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 days after the surgery will be learned by using the questionnaire.
    Time Frame
    48 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 hip replacement insertion not have a pacemaker or arrhythmia no history of pain, alcohol use or substance abuse no history of pain, alcohol use or substance abuse no history of pain, alcohol use or substance abuse 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 being I, II and III in the ASA classification of the American Society of Anesthesiology, agreeing to participate in the study. Exclusion Criteria: having a history of epilepsy Using analgesics at least 1 hour before TENS is applied the presence of a wound in the area where the electrode will be placed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Açelya Türkmen, PhD
    Phone
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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