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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06217263
Acronym
CABG
Enrollment
93
Registered
2024-01-22
Start date
2024-09-30
Completion date
2025-12-15
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pain, Postoperative pain, Coronary artery bypass surgery, Chest tube pain, vibration, cold application, pain management, nursing

Brief 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).

Interventions

Vibracool vibration device from Pain Care Labs was used. In another research group, the vibration device was combined with cold gel.

OTHERVibration device&Cold application pack

Pain Care Labs' Vibracool vibration device and cold gel pack will be used.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mediastinal Chest Tube PainT0: 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 removalMediastinal 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 PainT0: 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 removalThoracic 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.
AnxietyT0: 20 minutes before chest tube removal; T5: 15 minutes after chest tube removal; change score calculated as T5-T0Anxiety 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOROyku Kara, PhD

Istanbul University - Cerrahpasa

Participant flow

Recruitment details

A total of 93 patients undergoing coronary artery bypass graft surgery

Pre-assignment details

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.

Baseline characteristics

Characteristic
Age, Continuous60.26 years
STANDARD_DEVIATION 5.15
A history of surgery
No
20 Participants
A history of surgery
Yes
29 Participants
Alcohol use
No
57 Participants
Alcohol use
Yes
9 Participants
BMI
Normal
12 Participants
BMI
Overweight
81 Participants
Daily cigarette use
<1 pack of cigarettes
2 Participants
Daily cigarette use
>1 pack of cigarettes
8 Participants
Daily cigarette use
1 pack of cigarettes
12 Participants
Daily cigarette use
None
40 Participants
Diagnosis
Acute coronary syndrome
16 Participants
Diagnosis
Coronary artery disease
26 Participants
Educational status
Higher Education
5 Participants
Educational status
Primary Education
30 Participants
Educational status
Secondary Education
19 Participants
Employment status
No
47 Participants
Employment status
Yes
46 Participants
History of chronic disease
Hypertension
24 Participants
History of chronic disease
None
19 Participants
Marital status
Married
25 Participants
Marital status
Single
6 Participants
Number of bypass vessels
2 vessels
4 Participants
Number of bypass vessels
3 vessels
17 Participants
Number of bypass vessels
4-6 vessels
13 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
82 Participants
Smoking cessation situation
Continues
6 Participants
Smoking cessation situation
Didn't smoke
12 Participants
Smoking cessation situation
Quit
17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 310 / 31
other
Total, other adverse events
0 / 310 / 310 / 31
serious
Total, serious adverse events
0 / 310 / 310 / 31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026