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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Pain, Procedural; Coronary Artery Bypass Surgery; Chest Tubes
• Intervention / Treatment: Other: Vibration device&Cold application pack; Device: Vibration device

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Dr. Siyami Ersek Chest Cardiovascular Surgery Training and Research Hospital
  • Istanbul, Turkey (Türkiye)
    • IstanbulUC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: cold gel
Experimental: 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.	Other: Vibration device&Cold application pack; Pain Care Labs' Vibracool vibration device and cold gel pack will be used.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	T0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse rate	The pulse rate will be evaluated with the clinical patient monitor.	Change from baseline (before application) and 15-minute change after application
Oxygen saturation	The oxygen saturation will be evaluated with the clinical patient monitor.	Change from baseline (before application) and 15-minute change after application
Systolic and diastolic blood pressure	Systolic and diastolic blood pressure will be assessed with a cuffed clinical patient monitor.	Change from baseline (before application) and 15-minute change after application

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Collaborators: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• Investigators: Principal Investigator: Oyku Kara, PhD, Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: December 24, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; nursing; Postoperative pain; vibration; pain management; Coronary artery bypass surgery; cold application; Chest tube pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Pain; Pain, Postoperative; Agnosia
• Other Study ID Numbers: 3435-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes