Pain, ProceduralCABGNCT06217263
The Effect of Vibration and Cold on Pain and Anxiety Associated With Chest Tube Removal Following CABG
A study testing Vibration device and Vibration device&Cold application pack in people with Pain, Procedural and Pain, Postoperative, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
Removal of chest tubes after coronary artery bypass graft (CABG) surgery can cause severe pain and anxiety, which may negatively affect the recovery process. Integrating non-pharmacological methods into nursing care can help manage pain and anxiety safely and effectively. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Pain, Procedural, Pain, Postoperative, Coronary Artery Bypass Surgery
- What is being tested?
- Vibration device and Vibration device&Cold application pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had a chest tube placed for the first time, who already had mediastinal and thoracic chest tubes, who were classified as ASA (American Society of Anesthesiologists) III or below, who were between 40 and 65 years of age, and who were conscious, oriented, and cooperative were included in the study.
Who cannot join
- Patients with a chest tube in place for more than 72 hours, skin integrity issues around the chest tube or in the area where the procedure will be performed (scarring, laceration, erythema, inflammation, burns, infection), a history of coronary artery bypass graft surgery, a diagnosis of diabetes, a history of thoracotomy, being under the influence of anesthesia or analgesia, the development of complications during or after the surgical procedure, being intubated, presence of cold urticaria, inability to speak Turkish, hearing or vision problems, history of diagnosed psychiatric or mental illness, body mass index of 30 or above, and participation in another clinical trial during the same period were among the exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dr. Siyami Ersek Chest Cardiovascular Surgery Training and Research Hospital
Istanbul
IstanbulUC
Istanbul
About this study
Official title: The Effect of Vibration and Cold on Pain and Anxiety Associated With Chest Tube Removal Following Coronary Artery Bypass Graft Surgery: A Randomized Controlled Study
Removal of chest tubes after coronary artery bypass graft (CABG) surgery can cause severe pain and anxiety, which may negatively affect the recovery process. Integrating non-pharmacological methods into nursing care can help manage pain and anxiety safely and effectively.
This study was conducted to examine the effects of vibration therapy and vibration combined with cold application on pain and anxiety during chest tube removal. The study used a partial single-blind, randomized controlled experimental design. The research was carried out between September 2024 and June 2025 in a Cardiovascular Surgery Training and Research Hospital. A total of 93 patients who met the study criteria and agreed to participate were included. Patients were randomly assigned to one of three groups: a vibration group, a vibration plus cold application group, or a control group that received standard care.
Read more
Pain levels were measured using the Visual Analog Scale (VAS), and anxiety levels were measured using the State Anxiety Inventory (STAI-I). Measurements were taken six times: before chest tube removal, during the procedure, and after removal.
The results showed that vibration therapy significantly reduced pain and anxiety during chest tube removal. Patients who received vibration combined with cold application experienced further reductions in pain and anxiety and showed more stable vital signs. Patients in the vibration-only group reported higher satisfaction with the intervention.
In conclusion, vibration therapy is a safe, effective, and feasible nursing intervention for reducing pain and anxiety during chest tube removal after CABG surgery. Adding cold application to vibration enhances the effectiveness of the intervention. Based on these findings, integrating vibration therapy into nursing care is recommended, and combining it with cold application may be considered when clinically appropriate.
Read the detailed description
In patients undergoing Coronary Artery Bypass Graft (CABG) surgery, opening a sternotomy, cutting the intercostal nerves along the incision line, turning in bed, breathing, deep breathing, coughing, pleural irritation associated with the chest tube and removal of the chest tube are situations that cause pain. 74% of patients experience moderate to severe pain despite pharmacological treatment. After cardiothoracic surgery, a chest tube is placed in patients to maintain hemodynamic stability and cardiopulmonary function by evacuating air, blood, and fluid accumulated in the pleural, pericardial, or mediastinal space, and to prevent undesirable conditions such as pneumothorax, hemothorax, and pleural effusion. Chest tube removal (CTR); it is an experience that can cause moderate or severe pain and anxiety in patients due to friction and separation from the endothelium and other surrounding tissues in the entry area of the tube. Analgesic methods are often preferred in pain management.However, research reveals that patients experience pain during CTR despite the use of analgesics and anesthetics. Although pharmacological agents are the most commonly used method for pain relief during CTR, studies report that the response to pharmacological treatment is variable and may be inadequate for pain management during and after CTR, making pain management difficult. Considering that procedure-related anxiety disrupts the physiological and emotional state of the patient and the side effects and possible complications of analgesics used in pain management, such as respiratory distress and nausea, the importance of nurses' use of non-drug methods in reducing pain during CTR increases. In this context, the use of cold and vibration applications, which do not require invasive intervention, involves minimal risk, and can be easily applied by nurses, are practices that can contribute to the improvement of patient outcomes by reducing the pain experienced by the patient during CTR.
In the study, in order to determine the effect of vibration and cold application on pain and anxiety associated with chest tube removal after coronary artery bypass graft surgery, the calculation (d-value) method developed by Cohen was used to calculate the effect size to be used to determine the sample size to be included in the study. To determine the d value, which is the effect size index, the findings of the study reported by Yurdanur and Khorshid in 2010, which investigated the effect of cold application combined with standard analgesics on pain and anxiety during chest tube removal in patients undergoing thoracic surgery, were used. The effect size to be used in the research was calculated as d = 0.329. In this context, for the quantitative difference test (ANOVA test) between the three groups, d = 0.329, 95% confidence level (1-α), 80% test power (1-β) and 31 samples in each group using the G-power (version 3.1) package program. It was envisaged that a total of 93 participants would be taken as the sample group. A simple computer-assisted randomization method was used to distribute the groups homogeneously. For this purpose, the functions available on the website "https://www.random.org/integer-sets" were used.
Ethical permission was received for the research from the Clinical Research Ethics Committee (Decision No: 239, Date: 04.07.2023).
- Being tested
- Vibration device, Vibration device&Cold application pack
- Keywords
- Pain, Postoperative pain, Coronary artery bypass surgery, Chest tube pain, vibration, cold application, pain management, nursing
- Medical subject headings
- Pain, Procedural, Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration deviceDevice
Also called cold gel
Vibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel.
Vibration device&Cold application packOther
Pain Care Labs' Vibracool vibration device and cold gel pack will be used.
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | After coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. The vibration device will be placed in the upper quadrant proximal to the patient's drain tube entrance. Care will be taken to ensure that the point where the vibration device is placed is the same as the vibration device placement point in the vibration and cold application group. 10 minutes after the application, the patient's skin temperature will be measured and the vibration device will be pulled above the chest tube insertion area. Receives: Device: Vibration device |
| Vibration & Cold application | Experimental | After coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. Cold gel pack will be placed around the patient's chest tube insertion area. In order to optimize the effect of cold, the cold application will not exceed 20 minutes and the temperature of the skin will not fall below 12 ℃. At the 10th minute of cold application, the vibration device will be placed proximal to the chest tube, over the upper area of the cold gel pack. At the 20th minute of the application, the patient's skin temperature will be measured and the cold applied vibration device will be pulled above the chest tube insertion area. Receives: Other: Vibration device&Cold application pack |
| Control | No intervention | After coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. In the control group, the processes and monitoring in the application groups will be continued in the same period without the application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediastinal Chest Tube Pain
Mediastinal chest tube pain refers to the intensity of pain experienced by participants during and after removal of the mediastinal chest tube. Pain was assessed using the Visual Analog Scale for Pain (Visual Analog Scale, VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain severity. Measurements were obtained at predefined time points before, during, and after tube removal. Mediastinal chest tube pain was compared between the vibration, vibration combined with cold, and control groups at multiple predefined time points.
Measured: T0: 20 minutes before chest tube removal; T1: immediately before chest tube removal; T2: during chest tube removal; T3: 5 minutes after chest tube removal; T4: 10 minutes after chest tube removal; T5: 15 minutes after chest tube removal
Thoracic Chest Tube Pain
Thoracic chest tube pain refers to the intensity of pain experienced by participants during and after removal of the thoracic chest tube. Pain was assessed using the Visual Analog Scale for Pain (Visual Analog Scale, VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain severity. Measurements were obtained at predefined time points before, during, and after chest tube removal. Thoracic chest tube pain was compared between the vibration, vibration combined with cold, and control groups at multiple predefined time points.
Measured: T0: 20 minutes before chest tube removal; T1: immediately before chest tube removal; T2: during chest tube removal; T3: 5 minutes after chest tube removal; T4: 10 minutes after chest tube removal; T5: 15 minutes after chest tube removal
Anxiety
Anxiety refers to the level of situational anxiety experienced by participants in relation to chest tube removal. Anxiety was assessed using the State-Trait Anxiety Inventory - State Anxiety Form (STAI-I), a 20-item self-report scale with total scores ranging from 20 to 80, with higher scores indicating greater anxiety. Measurements were obtained at predefined time points before and after chest tube removal. State anxiety levels (STAI-I) did not differ between groups at baseline; however, after chest tube removal, both vibration and vibration combined with cold interventions significantly reduced state anxiety compared with the control group, with a greater reduction observed in the combined intervention, while trait anxiety levels (STAI-II) were similar between groups at baseline.
Measured: T0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start30 Sep 2024
- Primary completion30 Jun 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Oyku Kara, Istanbul University - Cerrahpasa
- Investigators
- Oyku Kara, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217263
- Sponsor's protocol ID
- 3435-123
- Acronym
- CABG
- Status last verified
- Mar 2026
- First submitted
- 24 Dec 2023
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to ethical and confidentiality considerations, the data cannot be made publicly available. However, the data may be obtained from the first author, Dr. Öykü Kara (oyku.kara@iuc.edu.tr), upon reasonable request and subject to approval by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibration and Cold on Pain and Anxiety Associated With Chest Tube Removal Following Coronary Artery Bypass Graft Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06217263
- Acronym / sponsor ID
- CABG / 3435-123
- Keywords
- Pain, Postoperative pain, Coronary artery bypass surgery, Chest tube pain, vibration, cold application, pain management, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Removal of chest tubes after coronary artery bypass graft (CABG) surgery can cause severe pain and anxiety, which may negatively affect the recovery process. Integrating non-pharmacological methods into nursing care can help manage pain and anxiety safely and effectively.
This study was conducted to examine the effects of vibration therapy and vibration combined with cold application on pain and anxiety during chest tube removal. The study used a partial single-blind, randomized controlled experimental design. The research was carried out between September 2024 and June 2025 in a Cardiovascular Surgery Training and Research Hospital. A total of 93 patients who met the study criteria and agreed to participate were included. Patients were randomly assigned to one of three groups: a vibration group, a vibration plus cold application group, or a control group that received standard care.
Pain levels were measured using the Visual Analog Scale (VAS), and anxiety levels were measured using the State Anxiety Inventory (STAI-I). Measurements were taken six times: before chest tube removal, during the procedure, and after removal.
The results showed that vibration therapy significantly reduced pain and anxiety during chest tube removal. Patients who received vibration combined with cold application experienced further reductions in pain and anxiety and showed more stable vital signs. Patients in the vibration-only group reported higher satisfaction with the intervention.
In conclusion, vibration therapy is a safe, effective, and feasible nursing intervention for reducing pain and anxiety during chest tube removal after CABG surgery. Adding cold application to vibration enhances the effectiveness of the intervention. Based on these findings, integrating vibration therapy into nursing care is recommended, and combining it with cold application may be considered when clinically appropriate.
Detailed description
In patients undergoing Coronary Artery Bypass Graft (CABG) surgery, opening a sternotomy, cutting the intercostal nerves along the incision line, turning in bed, breathing, deep breathing, coughing, pleural irritation associated with the chest tube and removal of the chest tube are situations that cause pain. 74% of patients experience moderate to severe pain despite pharmacological treatment. After cardiothoracic surgery, a chest tube is placed in patients to maintain hemodynamic stability and cardiopulmonary function by evacuating air, blood, and fluid accumulated in the pleural, pericardial, or mediastinal space, and to prevent undesirable conditions such as pneumothorax, hemothorax, and pleural effusion. Chest tube removal (CTR); it is an experience that can cause moderate or severe pain and anxiety in patients due to friction and separation from the endothelium and other surrounding tissues in the entry area of the tube. Analgesic methods are often preferred in pain management.However, research reveals that patients experience pain during CTR despite the use of analgesics and anesthetics. Although pharmacological agents are the most commonly used method for pain relief during CTR, studies report that the response to pharmacological treatment is variable and may be inadequate for pain management during and after CTR, making pain management difficult. Considering that procedure-related anxiety disrupts the physiological and emotional state of the patient and the side effects and possible complications of analgesics used in pain management, such as respiratory distress and nausea, the importance of nurses' use of non-drug methods in reducing pain during CTR increases. In this context, the use of cold and vibration applications, which do not require invasive intervention, involves minimal risk, and can be easily applied by nurses, are practices that can contribute to the improvement of patient outcomes by reducing the pain experienced by the patient during CTR.
In the study, in order to determine the effect of vibration and cold application on pain and anxiety associated with chest tube removal after coronary artery bypass graft surgery, the calculation (d-value) method developed by Cohen was used to calculate the effect size to be used to determine the sample size to be included in the study. To determine the d value, which is the effect size index, the findings of the study reported by Yurdanur and Khorshid in 2010, which investigated the effect of cold application combined with standard analgesics on pain and anxiety during chest tube removal in patients undergoing thoracic surgery, were used. The effect size to be used in the research was calculated as d = 0.329. In this context, for the quantitative difference test (ANOVA test) between the three groups, d = 0.329, 95% confidence level (1-α), 80% test power (1-β) and 31 samples in each group using the G-power (version 3.1) package program. It was envisaged that a total of 93 participants would be taken as the sample group. A simple computer-assisted randomization method was used to distribute the groups homogeneously. For this purpose, the functions available on the website "https://www.random.org/integer-sets" were used.
Ethical permission was received for the research from the Clinical Research Ethics Committee (Decision No: 239, Date: 04.07.2023).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Device: Vibration deviceAfter coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. The vibration device will be placed in the upper quadrant proximal to the patient's drain tube entrance. Care will be taken to ensure that the point where the vibration device is placed is the same as the vibration device placement point in the vibration and cold application group. 10 minutes after the application, the patient's skin temperature will be measured and the vibration device will be pulled above the chest tube insertion area. |
| Vibration & Cold application | Experimental | Other: Vibration device&Cold application packAfter coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. Cold gel pack will be placed around the patient's chest tube insertion area. In order to optimize the effect of cold, the cold application will not exceed 20 minutes and the temperature of the skin will not fall below 12 ℃. At the 10th minute of cold application, the vibration device will be placed proximal to the chest tube, over the upper area of the cold gel pack. At the 20th minute of the application, the patient's skin temperature will be measured and the cold applied vibration device will be pulled above the chest tube insertion area. |
| Control | No intervention | –After coronary artery bypass graft surgery, patients will receive routine monitoring, pharmacological treatment and nursing care in the unit where the research is conducted. In the control group, the processes and monitoring in the application groups will be continued in the same period without the application. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had a chest tube placed for the first time, who already had mediastinal and thoracic chest tubes, who were classified as ASA (American Society of Anesthesiologists) III or below, who were between 40 and 65 years of age, and who were conscious, oriented, and cooperative were included in the study.
Key exclusion criteria (1 listed)
- Patients with a chest tube in place for more than 72 hours, skin integrity issues around the chest tube or in the area where the procedure will be performed (scarring, laceration, erythema, inflammation, burns, infection), a history of coronary artery bypass graft surgery, a diagnosis of diabetes, a history of thoracotomy, being under the influence of anesthesia or analgesia, the development of complications during or after the surgical procedure, being intubated, presence of cold urticaria, inability to speak Turkish, hearing or vision problems, history of diagnosed psychiatric or mental illness, body mass index of 30 or above, and participation in another clinical trial during the same period were among the exclusion criteria.
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 |
|---|---|---|
| Vibration deviceAlso: cold gelVibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel. | Device | Vibration |
| Vibration device&Cold application packPain Care Labs' Vibracool vibration device and cold gel pack will be used. | Other | Vibration & Cold application |
Primary outcome
Mediastinal Chest Tube Pain
Time frame: T0: 20 minutes before chest tube removal; T1: immediately before chest tube removal; T2: during chest tube removal; T3: 5 minutes after chest tube removal; T4: 10 minutes after chest tube removal; T5: 15 minutes after chest tube removal
Mediastinal chest tube pain refers to the intensity of pain experienced by participants during and after removal of the mediastinal chest tube. Pain was assessed using the Visual Analog Scale for Pain (Visual Analog Scale, VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain severity. Measurements were obtained at predefined time points before, during, and after tube removal. Mediastinal chest tube pain was compared between the vibration, vibration combined with cold, and control groups at multiple predefined time points.
Thoracic Chest Tube Pain
Time frame: T0: 20 minutes before chest tube removal; T1: immediately before chest tube removal; T2: during chest tube removal; T3: 5 minutes after chest tube removal; T4: 10 minutes after chest tube removal; T5: 15 minutes after chest tube removal
Thoracic chest tube pain refers to the intensity of pain experienced by participants during and after removal of the thoracic chest tube. Pain was assessed using the Visual Analog Scale for Pain (Visual Analog Scale, VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain severity. Measurements were obtained at predefined time points before, during, and after chest tube removal. Thoracic chest tube pain was compared between the vibration, vibration combined with cold, and control groups at multiple predefined time points.
Anxiety
Time frame: T0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0
Anxiety refers to the level of situational anxiety experienced by participants in relation to chest tube removal. Anxiety was assessed using the State-Trait Anxiety Inventory - State Anxiety Form (STAI-I), a 20-item self-report scale with total scores ranging from 20 to 80, with higher scores indicating greater anxiety. Measurements were obtained at predefined time points before and after chest tube removal. State anxiety levels (STAI-I) did not differ between groups at baseline; however, after chest tube removal, both vibration and vibration combined with cold interventions significantly reduced state anxiety compared with the control group, with a greater reduction observed in the combined intervention, while trait anxiety levels (STAI-II) were similar between groups at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Due to ethical and confidentiality considerations, the data cannot be made publicly available. However, the data may be obtained from the first author, Dr. Öykü Kara (oyku.kara@iuc.edu.tr), upon reasonable request and subject to approval by the ethics committee.
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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.
Oyku Kara, PhD principal investigator
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration device and Vibration device&Cold application pack in people with Pain, Procedural and Pain, Postoperative, run by Istanbul University - Cerrahpasa at 2 sites 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 1 inclusion and 1 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mediastinal Chest Tube Pain (time frame: T0: 20 minutes before chest tube removal; T1: immediately before chest tube removal; T2: during chest tube removal; T3: 5 minutes after chest tube removal; T4: 10 minutes after chest tube removal; T5: 15 minutes after chest tube removal). 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 11 Mar 2026.