Trial Outcomes & Findings for The Effect of Vibration and Cold on Pain and Anxiety Associated With Chest Tube Removal Following CABG (NCT NCT06217263)

Last Updated: 2026-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

93 participants

Primary outcome timeframe

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

Results posted on

2026-03-11

Participant Flow

A total of 93 patients undergoing coronary artery bypass graft surgery

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.

Participant milestones

Participant milestones
Measure	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 & 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.	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.
Overall Study STARTED	31	31	31
Overall Study COMPLETED	31	31	31
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vibration n=31 Participants 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 n=31 Participants 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 n=31 Participants 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.	Total n=93 Participants Total of all reporting groups
Age, Continuous	57.32 years STANDARD_DEVIATION 7.12 • n=31 Participants	60.26 years STANDARD_DEVIATION 5.15 • n=31 Participants	57.42 years STANDARD_DEVIATION 6.78 • n=31 Participants	58.33 years STANDARD_DEVIATION 6.49 • n=93 Participants
Sex: Female, Male Female	4 Participants n=31 Participants	3 Participants n=31 Participants	4 Participants n=31 Participants	11 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=31 Participants	28 Participants n=31 Participants	27 Participants n=31 Participants	82 Participants n=93 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Marital status Married	26 Participants n=31 Participants	25 Participants n=31 Participants	26 Participants n=31 Participants	77 Participants n=93 Participants
Marital status Single	5 Participants n=31 Participants	6 Participants n=31 Participants	5 Participants n=31 Participants	16 Participants n=93 Participants
BMI Normal	3 Participants n=31 Participants	4 Participants n=31 Participants	5 Participants n=31 Participants	12 Participants n=93 Participants
BMI Overweight	28 Participants n=31 Participants	27 Participants n=31 Participants	26 Participants n=31 Participants	81 Participants n=93 Participants
Educational status Primary Education	13 Participants n=31 Participants	6 Participants n=31 Participants	11 Participants n=31 Participants	30 Participants n=93 Participants
Educational status Secondary Education	13 Participants n=31 Participants	19 Participants n=31 Participants	14 Participants n=31 Participants	46 Participants n=93 Participants
Educational status Higher Education	5 Participants n=31 Participants	6 Participants n=31 Participants	6 Participants n=31 Participants	17 Participants n=93 Participants
Employment status Yes	13 Participants n=31 Participants	14 Participants n=31 Participants	19 Participants n=31 Participants	46 Participants n=93 Participants
Employment status No	18 Participants n=31 Participants	17 Participants n=31 Participants	12 Participants n=31 Participants	47 Participants n=93 Participants
Diagnosis Coronary artery disease	26 Participants n=31 Participants	25 Participants n=31 Participants	26 Participants n=31 Participants	77 Participants n=93 Participants
Diagnosis Acute coronary syndrome	5 Participants n=31 Participants	6 Participants n=31 Participants	5 Participants n=31 Participants	16 Participants n=93 Participants
History of chronic disease None	7 Participants n=31 Participants	5 Participants n=31 Participants	7 Participants n=31 Participants	19 Participants n=93 Participants
History of chronic disease Hypertension	24 Participants n=31 Participants	26 Participants n=31 Participants	24 Participants n=31 Participants	74 Participants n=93 Participants
Daily cigarette use None	12 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	12 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	16 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	40 Participants n=93 Participants • Smoking status categories were defined based on participant self-report at baseline.
Daily cigarette use <1 pack of cigarettes	1 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	2 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	2 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	5 Participants n=93 Participants • Smoking status categories were defined based on participant self-report at baseline.
Daily cigarette use 1 pack of cigarettes	15 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	13 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	12 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	40 Participants n=93 Participants • Smoking status categories were defined based on participant self-report at baseline.
Daily cigarette use >1 pack of cigarettes	3 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	4 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	1 Participants n=31 Participants • Smoking status categories were defined based on participant self-report at baseline.	8 Participants n=93 Participants • Smoking status categories were defined based on participant self-report at baseline.
Smoking cessation situation Didn't smoke	12 Participants n=31 Participants	12 Participants n=31 Participants	16 Participants n=31 Participants	40 Participants n=93 Participants
Smoking cessation situation Quit	17 Participants n=31 Participants	13 Participants n=31 Participants	9 Participants n=31 Participants	39 Participants n=93 Participants
Smoking cessation situation Continues	2 Participants n=31 Participants	6 Participants n=31 Participants	6 Participants n=31 Participants	14 Participants n=93 Participants
Alcohol use No	22 Participants n=31 Participants	19 Participants n=31 Participants	16 Participants n=31 Participants	57 Participants n=93 Participants
Alcohol use Yes	9 Participants n=31 Participants	12 Participants n=31 Participants	15 Participants n=31 Participants	36 Participants n=93 Participants
A history of surgery No	20 Participants n=31 Participants	22 Participants n=31 Participants	22 Participants n=31 Participants	64 Participants n=93 Participants
A history of surgery Yes	11 Participants n=31 Participants	9 Participants n=31 Participants	9 Participants n=31 Participants	29 Participants n=93 Participants
Number of bypass vessels 2 vessels	4 Participants n=31 Participants	3 Participants n=31 Participants	4 Participants n=31 Participants	11 Participants n=93 Participants
Number of bypass vessels 3 vessels	15 Participants n=31 Participants	17 Participants n=31 Participants	14 Participants n=31 Participants	46 Participants n=93 Participants
Number of bypass vessels 4-6 vessels	12 Participants n=31 Participants	11 Participants n=31 Participants	13 Participants n=31 Participants	36 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vibration n=31 Participants Participants in this group received a 10-minute vibration application to the chest tube area immediately before chest tube removal.Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Vibration & Cold Application n=31 Participants Participants in this group received a 10-minute cold application followed by a simultaneous 10-minute cold and vibration application to the chest tube area immediately before chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Control n=31 Participants Participants in this group received no additional intervention before mediastinal chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.
Mediastinal Chest Tube Pain during mediastinal chest tube removal pain score	3.85 score on a scale Standard Deviation 1.11	3.00 score on a scale Standard Deviation 1.48	5.43 score on a scale Standard Deviation 1.04
Mediastinal Chest Tube Pain 20 minutes before mediastinal chest tube removal pain score	1.38 score on a scale Standard Deviation 1.44	1.76 score on a scale Standard Deviation 1.49	1.43 score on a scale Standard Deviation 1.59
Mediastinal Chest Tube Pain immediately before mediastinal chest tube removal pain score	0.21 score on a scale Standard Deviation 0.61	0.12 score on a scale Standard Deviation 0.49	1.50 score on a scale Standard Deviation 1.62
Mediastinal Chest Tube Pain 5 minutes after mediastinal chest tube removal pain score	0.78 score on a scale Standard Deviation 1.11	0.46 score on a scale Standard Deviation 0.98	2.65 score on a scale Standard Deviation 1.65
Mediastinal Chest Tube Pain 10 minutes after mediastinal chest tube removal pain score	0.04 score on a scale Standard Deviation 0.23	0.00 score on a scale Standard Deviation 0.00	0.53 score on a scale Standard Deviation 1.03
Mediastinal Chest Tube Pain 15 minutes after mediastinal chest tube removal pain score	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00	0.08 score on a scale Standard Deviation 0.33

PRIMARY outcome

Population: The analysis population included all randomized participants who underwent chest tube removal and were analyzed.

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.

Outcome measures

Outcome measures
Measure	Vibration n=31 Participants Participants in this group received a 10-minute vibration application to the chest tube area immediately before chest tube removal.Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Vibration & Cold Application n=31 Participants Participants in this group received a 10-minute cold application followed by a simultaneous 10-minute cold and vibration application to the chest tube area immediately before chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Control n=31 Participants Participants in this group received no additional intervention before mediastinal chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.
Thoracic Chest Tube Pain 20 minutes before thoracic chest tube removal pain score	3.34 score on a scale Standard Deviation 1.80	3.98 score on a scale Standard Deviation 1.29	2.93 score on a scale Standard Deviation 1.89
Thoracic Chest Tube Pain 10 minutes after thoracic chest tube removal pain score	0.50 score on a scale Standard Deviation 0.85	0.05 score on a scale Standard Deviation 0.29	2.56 score on a scale Standard Deviation 1.68
Thoracic Chest Tube Pain immediately before thoracic chest tube removal pain score	1.01 score on a scale Standard Deviation 1.25	0.65 score on a scale Standard Deviation 1.14	2.93 score on a scale Standard Deviation 1.89
Thoracic Chest Tube Pain during thoracic chest tube removal pain score	6.39 score on a scale Standard Deviation 0.91	5.69 score on a scale Standard Deviation 1.06	8.33 score on a scale Standard Deviation 1.09
Thoracic Chest Tube Pain 5 minutes after thoracic chest tube removal pain score	2.67 score on a scale Standard Deviation 1.35	1.21 score on a scale Standard Deviation 1.31	5.38 score on a scale Standard Deviation 1.49
Thoracic Chest Tube Pain 15 minutes after thoracic chest tube removal pain score	0.04 score on a scale Standard Deviation 0.23	0.00 score on a scale Standard Deviation 0.00	0.60 score on a scale Standard Deviation 1.09

PRIMARY outcome

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

Population: The analysis population included all randomized participants who underwent chest tube removal and were analyzed.

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.

Outcome measures

Outcome measures
Measure	Vibration n=31 Participants Participants in this group received a 10-minute vibration application to the chest tube area immediately before chest tube removal.Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Vibration & Cold Application n=31 Participants Participants in this group received a 10-minute cold application followed by a simultaneous 10-minute cold and vibration application to the chest tube area immediately before chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.	Control n=31 Participants Participants in this group received no additional intervention before mediastinal chest tube removal. Pain and anxiety levels were assessed at predefined time points before and after chest tube removal.
Anxiety 20 minutes before chest tube removal anxiety score (T0)	38.19 score on a scale Standard Deviation 6.07	41.16 score on a scale Standard Deviation 6.13	39.16 score on a scale Standard Deviation 6.97
Anxiety 15 minutes after chest tube removal anxiety score (T5)	25.74 score on a scale Standard Deviation 3.35	24.68 score on a scale Standard Deviation 2.70	50.32 score on a scale Standard Deviation 7.63
Anxiety Anxiety score change (T5-T0)	-12.45 score on a scale Standard Deviation 5.58	-16.48 score on a scale Standard Deviation 6.25	11.16 score on a scale Standard Deviation 5.51

Adverse Events

Vibration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibration & Cold Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Assistant Dr. Öykü KARA

Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing

Phone: +90 212 224 2618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place