Effects of TENS in Patients Admitted to the ICU After Cardiac Surgery (ETENSCS)

Effects of TENS Application in Patients Admitted to the ICU After Cardiac Surgery: a Randomized Double-blind Clinical Trial

Cardiac Surgery (CH) aims to increase survival and improve quality of life in eligible cardiac patients. However, as with any invasive intervention, pain is one of the main complaints of patients in the post-surgical period. This research is justified by the evaluation of the potential impact of the use of TENS as an alternative for analgesia in reducing the length of hospital stay and directly in the effective cost of patients undergoing cardiac surgeries, in reducing morbidity and mortality, as well as in the quality of life and early return to their daily activities, in addition to reducing the use of drugs and potentially their side effects. The objective of this study is to evaluate the effect of TENS for analgesia in hospitalized patients undergoing cardiac surgery, investigating its efficacy, safety and impact on postoperative recovery.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Transcutaneous Electric Nerve Stimulation
• Intervention / Treatment: Device: Placebo; Device: Conventional TENS; Device: TENS low frequence group

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • UFPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of both sexes
• over 18 years of age,
• undergoing elective cardiac surgery,
• who have a sternotomy access route,
• with or without the use of pleural or mediastinal drains,
• after the first postoperative day will be selected.

Exclusion Criteria:

• with unstable angina,
• patients with arrhythmias,
• whether symptomatic or asymptomatic,
• with changes in the level of consciousness and cognition that may interfere with the assessment,
• use of metal implants,
• pacemakers and implantable cardioverter (ICD),
• those who presented postoperative complications such as infection in the sternotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; This group will not actually receive a treatment current, being subjected only to the device connected without current.	Device: Placebo; these patients will be subjected to the same usual routine of pharmacological analgesia, consisting of the administration of 1g of dipyrone at the discretion, with escalation to tramal (dose) and physiotherapy in the hospital ICU, in addition to an application of TENS, with the device turned on, with programming on channels that are not connected to the patients, so as to generate visual and auditory feedback.
Experimental: TENS convencional group; In this group, patients will undergo the hospital's usual analgesia and physiotherapy routine, plus TENS with a frequency of 140 Hz and a pulse width of 50 µs.	Device: Conventional TENS; In this group, patients will undergo the usual routine of analgesia and hospital physiotherapy, in addition to TENS with a frequency of 140 Hz, pulse width of 50 µs.
Experimental: TENS low frequence group; Patients in this group will undergo the hospital's usual analgesia and physiotherapy routine, plus conventional TENS with a low frequency of 5 Hz and a pulse width of 250 µs	Device: TENS low frequence group; Patients in this group will undergo the hospital usual analgesia and physiotherapy routine, in addition to conventional TENS with a low frequency of 5 Hz and a pulse width of 250 µs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory muscle strength	measured in centimeters of water	through study completion, an average of 1 year
cough peak flow	measured in liters per minute	through study completion, an average of 1 year
slow vital capacity	measured in milliliters per kilo	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
painful sensation	Zero is equivalent to no pain and 10 indicates the worst possible pain.	through study completion, an average of 1 year
length of stay	measured in days	through study completion, an average of 1 year
cardiac variability	measured in beats per minute	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: October 27, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: thoracic surgery; transcutaneous electrical nerve stimulation; heart surgery; tens; cardiac surgical procesures
• Other Study ID Numbers: 76710723.0.0000.5201 (Other Identifier: Plataforma Brasil)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No