Transcutaneous Electrical Nerve StimulationNCT05927168
Effect of TENS Application After Thoracic Surgery
A study testing TENS in people with Transcutaneous Electrical Nerve Stimulation and Procedural Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
After thoracic surgery, a chest tube is inserted to evacuate the air and fluid formed in the pleural space and to provide hemodynamic stability. During chest tube placement, subcutaneous tissue layers, muscles and parietal pleura are passed through. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Procedural Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to Dec 2023
- 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
- be over 18 years old
- no chest tube
- not have a pacemaker or arrhythmia
- no history of pain, alcohol use or substance abuse
- no prior pre-operative TENS/opioid use
- no postoperative epidural analgesics
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- no history of psychiatric illness
- no history of metastatic disease
- being conscious, able to speak
- no barriers to the application of TENS
- no postoperative complications and being I, II and III in the ASA classification of the American Society of Anesthesiology.
Who cannot join
- having a history of epilepsy
- using analgesics at least 1 hour before chest tube removal.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University
Adana, Sarıcam, 01380
Acelya TURKMEN, PhD, +9005424383439, acelyaturkmen2@gmail.com.tr
Sevilay ERDEN, PhD, +9005393231872, sevilaygil@gmail.com
About this study
Official title: Effect of TENS Application After Thoracic Surgery on Pain Level and Analgesic Consumption During Breast Tube Extraction
After thoracic surgery, a chest tube is inserted to evacuate the air and fluid formed in the pleural space and to provide hemodynamic stability. During chest tube placement, subcutaneous tissue layers, muscles and parietal pleura are passed through. This process is a trauma and the affected tissues show an inflammatory reaction to the trauma. The chest tube adheres to the tissue it comes into contact with and may experience mild, moderate and severe pain due to the separation of the adhesion due to pulling during removal. Chest tube removal is described as a severely painful procedure in studies. Analgesics are generally used in the treatment of acute pain during chest tube removal (Wei et al. 2022). However, pain guidelines and studies recommend the use of analgesics with non-pharmacological methods in order to minimize the pain experienced during chest tube removal and to provide adequate analgesia. One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). TENS, an electroanalgesia method, helps to control pain by providing skin stimulation through surface electrodes placed on the skin.While there are studies in the literature on the use of TENS in reducing the pain caused by chest tube removal after different surgical interventions, there are limited studies investigating the effect of TENS on the level of pain during chest tube removal and postoperative analgesic consumption after thoracic surgery. In this context, in this study, it is aimed to determine the effect of TENS application after thoracic surgery on pain level and analgesic requirement during chest tube removal.
Read the detailed description
One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). Nurses play an important role in patient follow-up after surgery. It also has the responsibility to administer analgesics with the least side effects and the most effect. The New York Association of Nurses states that TENS is a complementary treatment method and its application strengthens the professional independence of nurses. However, as a result of our studies and observations, it is seen that there is no protocol for the use of TENS after thoracic surgery. TENS is applied together with physicians according to the nursing regulations in Turkey. Postoperative pain management requires team collaboration. Therefore, nurses should play a key role in pain management and use non-pharmacological methods.
- Being tested
- TENS
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed. Patients' pain scores will be evaluated using the Numerical Pain Scale (SAS) just before the TENS procedure, while the chest tube is removed, and 5 minutes after the TENS application is finished.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | TENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed. Receives: Device: TENS |
| Control group | No intervention | TENS will not be applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the pain level
Reducing the pain level of patients by applying TENS. Patients' pain scores before, during and after the procedure will be evaluated using the VAS.
Measured: 1 hour
Change in analgesic consumption
Reducing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 hour after the procedure will be learned by using the questionnaire.
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jun 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Nerve StimulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acelya Turkmen, Cukurova University
- Investigators
- Açelya Türkmen, PhD, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927168
- Sponsor's protocol ID
- CU-SBF-AT-04
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TENS Application After Thoracic Surgery on Pain Level and Analgesic Consumption During Breast Tube Extraction
- ClinicalTrials.gov ID
- NCT05927168
- Acronym / sponsor ID
- CU-SBF-AT-04
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Jul 2023 (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.
After thoracic surgery, a chest tube is inserted to evacuate the air and fluid formed in the pleural space and to provide hemodynamic stability. During chest tube placement, subcutaneous tissue layers, muscles and parietal pleura are passed through. This process is a trauma and the affected tissues show an inflammatory reaction to the trauma. The chest tube adheres to the tissue it comes into contact with and may experience mild, moderate and severe pain due to the separation of the adhesion due to pulling during removal. Chest tube removal is described as a severely painful procedure in studies. Analgesics are generally used in the treatment of acute pain during chest tube removal (Wei et al. 2022). However, pain guidelines and studies recommend the use of analgesics with non-pharmacological methods in order to minimize the pain experienced during chest tube removal and to provide adequate analgesia. One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). TENS, an electroanalgesia method, helps to control pain by providing skin stimulation through surface electrodes placed on the skin.While there are studies in the literature on the use of TENS in reducing the pain caused by chest tube removal after different surgical interventions, there are limited studies investigating the effect of TENS on the level of pain during chest tube removal and postoperative analgesic consumption after thoracic surgery. In this context, in this study, it is aimed to determine the effect of TENS application after thoracic surgery on pain level and analgesic requirement during chest tube removal.
Detailed description
One of the non-pharmacological methods used in pain management is Transcutaneous Electrical Nerve Stimulation (TENS). Nurses play an important role in patient follow-up after surgery. It also has the responsibility to administer analgesics with the least side effects and the most effect. The New York Association of Nurses states that TENS is a complementary treatment method and its application strengthens the professional independence of nurses. However, as a result of our studies and observations, it is seen that there is no protocol for the use of TENS after thoracic surgery. TENS is applied together with physicians according to the nursing regulations in Turkey. Postoperative pain management requires team collaboration. Therefore, nurses should play a key role in pain management and use non-pharmacological methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: TENSTENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed. |
| Control group | No intervention | –TENS will not be applied to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- be over 18 years old
- no chest tube
- not have a pacemaker or arrhythmia
- no history of pain, alcohol use or substance abuse
- no prior pre-operative TENS/opioid use
Key exclusion criteria (2 listed)
- having a history of epilepsy
- using analgesics at least 1 hour before chest tube removal.
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 |
|---|---|---|
| TENSTENS will be applied to the experimental group 45 minutes before the chest tube is removed and another 15 minutes after the chest tube is removed. Patients' pain scores will be evaluated using the Numerical Pain Scale (SAS) just before the TENS procedure, while the chest tube is removed, and 5 minutes after the TENS application is finished. | Device | TENS group |
Primary outcome
Change in the pain level
Time frame: 1 hour
Reducing the pain level of patients by applying TENS. Patients' pain scores before, during and after the procedure will be evaluated using the VAS.
Change in analgesic consumption
Time frame: 2 hour
Reducing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 hour after the procedure will be learned by using the questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Açelya Türkmen, PhD principal investigator
Cukurova University
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 in people with Transcutaneous Electrical Nerve Stimulation and Procedural Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Açelya Türkmen (+90 05424383439, acelyaturkmen2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pain level (time frame: 1 hour). The study lists 2 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 3 Jul 2023.