Clinical trial NCT06217263: Effect of Vibration and Cold Application on Chest Tube Removal Pain After CABG
Official title: Effect of Vibration and Cold Application on Chest Tube Removal Pain After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Procedural
Pain, Postoperative
Coronary Artery Bypass Surgery
Chest Tubes
Keywords: Pain
Postoperative pain
Coronary artery bypass surgery
Chest tube pain
vibration
cold application
pain management
nursing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
First posted: 2024-01-22
Enrollment: 93
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 This research was designed as a randomized controlled experimental study 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 research was planned to be conducted in the Cardiovascular Surgery Intensive Care Unit and Surgical Services of a Thoracic and Cardiovascular Surgery Training and Research Hospital in Istanbul between January 2024 and January 2025. Patients' pain will be evaluated using VAS, blood pressure, and respiratory rate using a patient monitor, pulse and oxygen saturation using a pulse oximeter device, and the temperature of cold application gels using a digital infrared thermometer. All data will be collected by the same researcher, with the same tools and methods. A "data form" developed in line with the literature and STAI I-II (State and Trait Anxiety Scale) will be used as data collection tools.

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). Device usage permission is awaited from the Turkish Medicines and Medical Devices Agency.

Eligibility criteria: Inclusion Criteria:

* A chest tube was placed for the first time
* ASA (American Society of Anesthesiology) classification I and II
* Those between the ages of 40-65
* Conscious, oriented and cooperative
* Patients who agree to participate in the research verbally and in writing after being informed about the research

Exclusion Criteria:

* Having a chest tube for more than 72 hours
* More than one chest tube entry and removed at the same time
* A chest tube was removed from the area close to the sternotomy line
* Having compromised skin integrity (burn, laceration, scar, inflammation, infection, erythema) around the chest tube and in the application area
* Having a history of thoracotomy
* Those who are intubated
* Those with cold urticaria
* Under the influence of anesthesia or analgesia
* Complications developed during or after surgical intervention
* Those who do not speak Turkish and have hearing and vision problems
* Having a diagnosed psychiatric disease or mental problem
* Having a body mass index ≥30
* Patients who participated in another clinical trial during the same period

Primary outcomes:
measure: Assessment of pain using the Visual Analog Scale
timeFrame: Change from baseline (before application) and 15-minute change after application
measure: Assessment of pain using the The State-Trait Anxiety Inventory Scale
timeFrame: Change from baseline (before application) and 15-minute change after application
Secondary outcomes:
measure: Pulse rate
timeFrame: Change from baseline (before application) and 15-minute change after application
measure: Oxygen saturation
timeFrame: Change from baseline (before application) and 15-minute change after application
measure: Systolic and diastolic blood pressure
timeFrame: Change from baseline (before application) and 15-minute change after application
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: IstanbulUC
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Oyku Kara, MSc
role: PRINCIPAL_INVESTIGATOR
References: