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

NCT06217263 | Completed Results FDA Device

• 1 other identifier: 3435-123
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Vibration

EXPERIMENTAL

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

Vibration & Cold application

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Vibration device DEVICE

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

Also known as: cold gel

Vibration

Vibration device&Cold application pack OTHER

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

Vibration & Cold application

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: collaborator
• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Dr. Siyami Ersek Chest Cardiovascular Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

IstanbulUC

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Research Assistant Dr. Öykü KARA
• Organization: Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing

oyku.kara@iuc.edu.tr

+90 212 224 2618

Study Officials

• Oyku Kara, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Nursing Research Assistant (PhD)

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 22, 2024
• Study Start: September 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 15, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)