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

NCT05939804 | Not Yet Recruiting

• 1 other identifier: CU-SBF-AT-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Pain, Postoperative; Analgesia

Keywords

Hip Replacement; Transcutaneous Electrical Nerve Stimulation; Pain; Analgesia

Outcome Measures

Primary Outcomes (2)

• 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

  48 hour

• 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.

  48 hour

Study Arms (2)

TENS group

EXPERIMENTAL

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.

Device: TENS

Control group

NO INTERVENTION

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

Interventions

TENS 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.

TENS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative; Agnosia; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Açelya Türkmen, PhD

  Cukurova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Açelya Türkmen, PhD

CONTACT

+903223386084; acelyaturkmen2@gmail.com

Sevilay Erden, PhD

CONTACT

+903223386084; serden@cu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)