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

NCT ID: NCT05939804

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-09-01

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.

Conditions

Hip Fractures; Pain, Postoperative; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TENS group

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TENS

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Acelya Turkmen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Açelya Türkmen, PhD

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Cukurova University

Adana, Adana, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Açelya Türkmen, PhD

Role: CONTACT

acelyaturkmen2@gmail.com

+903223386084

Sevilay Erden, PhD

Role: CONTACT

serden@cu.edu.tr

+903223386084

Other Identifiers

CU-SBF-AT-05

Identifier Type: -

Identifier Source: org_study_id