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

NCT06664242 | Completed

• 1 other identifier: 76710723.0.0000.5201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery; Transcutaneous Electric Nerve Stimulation

Keywords

tens; transcutaneous electrical nerve stimulation; heart surgery; cardiac surgical procesures; thoracic surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• painful sensation

  through study completion, an average of 1 year

• length of stay

  through study completion, an average of 1 year

• cardiac variability

  through study completion, an average of 1 year

Study Arms (3)

Control Group

PLACEBO COMPARATOR

This group will not actually receive a treatment current, being subjected only to the device connected without current.

Device: Placebo

TENS convencional group

EXPERIMENTAL

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

TENS low frequence group

EXPERIMENTAL

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

Interventions

Placebo DEVICE

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.

Control Group

TENS low frequence group DEVICE

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.

TENS low frequence group

Conventional TENS DEVICE

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.

TENS convencional group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

UFPE

Recife, Pernambuco, 50670-901, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: October 29, 2024
• Study Start: May 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 24, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

BR (1)