NCT06217263

The Effect of Vibration and Cold on Pain and Anxiety Associated With Chest Tube Removal Following CABG

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Pain, Procedural
• Pain, Postoperative
• Coronary Artery Bypass Surgery
• Chest Tubes

Interventions

Type	Name	Description
DEVICE	Vibration device	Vibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel.
OTHER	Vibration device&Cold application pack	Pain Care Labs' Vibracool vibration device and cold gel pack will be used.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-06-30
• Completion: 2025-12-15
• First posted: 2024-01-22
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

2 sites across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study