Effect of TENS Application After Thoracic Surgery

NCT05927168 | Unknown

• 1 other identifier: CU-SBF-AT-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electrical Nerve Stimulation; Procedural Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  1 hour

• 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.

  2 hour

Study Arms (2)

TENS group

EXPERIMENTAL

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.

Device: TENS

Control group

NO INTERVENTION

TENS will not be applied to the control group

Interventions

TENS DEVICE

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.

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
• 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.

You may not qualify if:

• having a history of epilepsy
• using analgesics at least 1 hour before chest tube removal.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01380, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

CONTACT

+90 05424383439; acelyaturkmen2@gmail.com

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: PhD

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)