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

NCT ID: NCT06664242

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-03-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Conventional TENS

Intervention Type: 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 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

Group Type: EXPERIMENTAL

TENS low frequence group

Intervention Type: 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.

Interventions

Placebo

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.

Intervention Type: DEVICE

TENS 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.

Intervention Type: DEVICE

Conventional 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Max de Araujo Melo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UFPE

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

76710723.0.0000.5201

Identifier Type: OTHER

Identifier Source: secondary_id

76710723.0.0000.5201

Identifier Type: -

Identifier Source: org_study_id