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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06664242
Acronym
ETENSCS
Enrollment
10
Registered
2024-10-29
Start date
2024-05-01
Completion date
2025-03-24
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Transcutaneous Electric Nerve Stimulation

Keywords

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

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.

Interventions

DEVICEPlacebo

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.

DEVICETENS 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.

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.

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
respiratory muscle strengththrough study completion, an average of 1 yearmeasured in centimeters of water
cough peak flowthrough study completion, an average of 1 yearmeasured in liters per minute
slow vital capacitythrough study completion, an average of 1 yearmeasured in milliliters per kilo

Secondary

MeasureTime frameDescription
painful sensationthrough study completion, an average of 1 yearZero is equivalent to no pain and 10 indicates the worst possible pain.
length of staythrough study completion, an average of 1 yearmeasured in days
cardiac variabilitythrough study completion, an average of 1 yearmeasured in beats per minute

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026