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Completed

NCT Number: NCT06664242

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

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.

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Key information

Conditions

Cardiac Surgery Transcutaneous Electric Nerve Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFPE

Recife, Pernambuco, 50670-901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. respiratory muscle strength

    Time frame: through study completion, an average of 1 year

    measured in centimeters of water

  2. cough peak flow

    Time frame: through study completion, an average of 1 year

    measured in liters per minute

  3. slow vital capacity

    Time frame: through study completion, an average of 1 year

    measured in milliliters per kilo

Secondary outcomes

  1. painful sensation

    Time frame: through study completion, an average of 1 year

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

  2. length of stay

    Time frame: through study completion, an average of 1 year

    measured in days

  3. cardiac variability

    Time frame: through study completion, an average of 1 year

    measured in beats per minute

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Acronym: ETENSCS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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