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

U

Universidade Federal de Pernambuco

Status

Completed

Conditions

Cardiac Surgery
Transcutaneous Electric Nerve Stimulation

Treatments

Device: Conventional TENS
Device: TENS low frequence group
Device: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06664242
76710723.0.0000.5201 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

10 participants in 3 patient groups, including a placebo group

Control Group
Placebo Comparator group
Description:
This group will not actually receive a treatment current, being subjected only to the device connected without current.
Treatment:
Device: Placebo
TENS convencional group
Experimental group
Description:
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.
Treatment:
Device: Conventional TENS
TENS low frequence group
Experimental group
Description:
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
Treatment:
Device: TENS low frequence group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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