Cardiac SurgeryETENSCSNCT06664242
Effects of TENS in Patients Admitted to the ICU After Cardiac Surgery
A study testing TENS low frequence group and Conventional TENS in people with Cardiac Surgery and Transcutaneous Electric Nerve Stimulation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Transcutaneous Electric Nerve Stimulation
- What is being tested?
- TENS low frequence group and Conventional TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of TENS Application in Patients Admitted to the ICU After Cardiac Surgery: a Randomized Double-blind Clinical Trial
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.
- Being tested
- Placebo, TENS low frequence group, Conventional TENS
- Keywords
- tens, transcutaneous electrical nerve stimulation, heart surgery, cardiac surgical procesures, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDevice
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 groupDevice
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 TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | This group will not actually receive a treatment current, being subjected only to the device connected without current. Receives: Device: Placebo |
| TENS convencional group | Experimental | 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. Receives: Device: Conventional TENS |
| TENS low frequence group | Experimental | 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 Receives: Device: TENS low frequence group |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory muscle strength
measured in centimeters of water
Measured: through study completion, an average of 1 year
cough peak flow
measured in liters per minute
Measured: through study completion, an average of 1 year
slow vital capacity
measured in milliliters per kilo
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
painful sensation
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: through study completion, an average of 1 year
length of stay
measured in days
Measured: through study completion, an average of 1 year
cardiac variability
measured in beats per minute
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 May 2024
- Primary completion28 Feb 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max de Araujo Melo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664242
- Sponsor's protocol ID
- 76710723.0.0000.5201
- Other IDs
- 76710723.0.0000.5201
- Acronym
- ETENSCS
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TENS Application in Patients Admitted to the ICU After Cardiac Surgery: a Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06664242
- Acronym / sponsor ID
- ETENSCS / 76710723.0.0000.5201
- Keywords
- tens, transcutaneous electrical nerve stimulation, heart surgery, cardiac surgical procesures, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Device: PlaceboThis group will not actually receive a treatment current, being subjected only to the device connected without current. |
| TENS convencional group | Experimental | Device: Conventional TENSIn 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. |
| TENS low frequence group | Experimental | Device: TENS low frequence groupPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebothese 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. | Device | Control Group |
| TENS low frequence groupPatients 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. | Device | TENS low frequence group |
| Conventional TENSIn 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. | Device | TENS convencional group |
Primary outcome
respiratory muscle strength
Time frame: through study completion, an average of 1 year
measured in centimeters of water
cough peak flow
Time frame: through study completion, an average of 1 year
measured in liters per minute
slow vital capacity
Time frame: through study completion, an average of 1 year
measured in milliliters per kilo
3 secondary outcomes
painful sensation
Time frame: through study completion, an average of 1 year
length of stay
Time frame: through study completion, an average of 1 year
cardiac variability
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS low frequence group and Conventional TENS in people with Cardiac Surgery and Transcutaneous Electric Nerve Stimulation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory muscle strength (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.