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CompletedNCT06664242ETENSCSUpdated Mar 25, 2025

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

An interventional study of Placebo and TENS low frequence group in Cardiac Surgery and Transcutaneous Electric Nerve Stimulation, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2024, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgery
  • Transcutaneous Electric Nerve Stimulation

Keywords

  • tens
  • transcutaneous electrical nerve stimulation
  • heart surgery
  • cardiac surgical procesures
  • thoracic surgery
03

In context

Lead sponsor

Universidade Federal de Pernambuco is the lead sponsor of 161 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    Control Group

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

    Device: Placebo

  • 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

  • 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

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.

  • DeviceConventional 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.

06

What researchers measure

Primary outcomes

  1. respiratory muscle strength

    measured in centimeters of water

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

  2. cough peak flow

    measured in liters per minute

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

  3. slow vital capacity

    measured in milliliters per kilo

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

Secondary outcomes

  1. painful sensation

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

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

  2. length of stay

    measured in days

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

  3. cardiac variability

    measured in beats per minute

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

07

Study locations

1 site
  • UFPE
    Recife, Pernambuco 50670-901, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06664242
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Max de Araujo Melo (Principal Investigator, Universidade Federal de Pernambuco) — Principal investigator
First posted
Oct 29, 2024
Start date
May 1, 2024
Primary completion
Feb 28, 2025
Completion
Mar 24, 2025
Last update
Mar 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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