Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital | OTHER |
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration device | Device | Vibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oyku Kara, PhD | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Siyami Ersek Chest Cardiovascular Surgery Training and Research Hospital | Istanbul | Turkey (Türkiye) | ||||
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.
Not provided
Not provided
Not provided
Not provided
Participants were selected from a Thoracic and Cardiovascular Surgery Training and Research Hospital between September 2024 and June 2025. Applications were submitted from consecutive, research-criteria-meeting, randomly selected patients scheduled for chest tube removal after coronary artery bypass graft surgery.
A total of 93 patients undergoing coronary artery bypass graft surgery
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vibration | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Statistical Analysis | Jun 14, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vibration device&Cold application pack | Other | Pain Care Labs' Vibracool vibration device and cold gel pack will be used. |
|
| T0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0 |
| IstanbulUC |
| Istanbul |
| Turkey (Türkiye) |
| FG001 | Vibration & Cold Application | 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. |
| FG002 | Control | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline characteristics were assessed for all randomized participants (N=93; 31 per group).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vibration | 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. |
| BG001 | Vibration & Cold Application | 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. |
| BG002 | Control | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was recorded in years at the time of study enrollment and prior to randomization. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Marital status | Count of Participants | Participants |
| |||||||||||
| BMI | Body mass index (BMI) was calculated at baseline as weight in kilograms divided by height in meters squared (kg/m²) prior to randomization. | Count of Participants | Participants |
| ||||||||||
| Educational status | Educational status was recorded at baseline based on participant self-report prior to randomization. | Count of Participants | Participants |
| ||||||||||
| Employment status | Employment status was recorded at baseline based on participant self-report and categorized according to current working status prior to randomization. | Count of Participants | Participants |
| ||||||||||
| Diagnosis | Diagnosis was recorded at baseline based on medical records and physician documentation. | Count of Participants | Participants |
| ||||||||||
| History of chronic disease | History of chronic disease was recorded at baseline based on participant self-report and review of medical records. | Count of Participants | Participants |
| ||||||||||
| Daily cigarette use | Smoking status categories were defined based on participant self-report at baseline. | Count of Participants | Participants |
| ||||||||||
| Smoking cessation situation | Smoking cessation status was recorded at baseline based on participant self-report. | Count of Participants | Participants |
| ||||||||||
| Alcohol use | Alcohol use was recorded at baseline based on participant self-report. | Count of Participants | Participants |
| ||||||||||
| A history of surgery | A history of surgery was recorded at baseline based on participant self-report and review of medical records. | Count of Participants | Participants |
| ||||||||||
| Number of bypass vessels | The number of bypass vessels was recorded at baseline based on operative records. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | 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. | The analysis population included all randomized participants who underwent chest tube removal and were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 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 |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | The analysis population included all randomized participants who underwent chest tube removal and were analyzed. | Posted | Mean | Standard Deviation | score on a scale | T0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0 |
|
3 day
Adverse events were defined as skin injury, excessive pain, intolerance to cold, or any event requiring termination of the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vibration | 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. Vibration device: Vibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Vibration & Cold Application | 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. Vibration device&Cold application pack: Pain Care Labs' Vibracool vibration device and cold gel pack will be used. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Control | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant Dr. Öykü KARA | Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing | +90 212 224 2618 | 27107 | oyku.kara@iuc.edu.tr |
| Feb 13, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2024 | Feb 13, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| during mediastinal chest tube removal pain score |
|
| 5 minutes after mediastinal chest tube removal pain score |
|
| 10 minutes after mediastinal chest tube removal pain score |
|
| 15 minutes after mediastinal chest tube removal pain score |
|
| OG002 | Control | Participants in this group received no additional intervention before chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal. |
|
|
| OG002 | Control | Participants in this group received no additional intervention before chest tube removal. State anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI-I) before and after the procedure at predefined time points. |
|
|
|