- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327957
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
The Effect of Vibration and Breathing Exercises Applied Before Chest Tube Removal on Pain and Anxiety: A Randomized Controlled Trial
Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Therefore, simple and safe non-drug methods are increasingly used to improve patient comfort.
This randomized controlled study aims to examine the effects of vibration and breathing exercises applied before chest tube removal on patients' pain and anxiety levels. Adult patients with a chest tube will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving standard care. Pain and anxiety levels will be measured before the procedure and after chest tube removal using validated scales.
The findings of this study are expected to show whether vibration and breathing exercises are effective in reducing pain and anxiety during chest tube removal. If effective, these methods may offer nurses an easy, low-cost, and safe way to improve patient comfort and support evidence-based nursing care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chest tube removal is a necessary clinical procedure following thoracic surgery, but it is frequently associated with acute pain and heightened anxiety. These symptoms may negatively affect patient comfort, cooperation, and recovery. While pharmacological interventions are commonly used to manage procedure-related pain and anxiety, concerns regarding side effects and limited effectiveness have increased interest in non-pharmacological approaches within nursing care.
This randomized controlled study is designed to evaluate the effectiveness of vibration and breathing exercises applied prior to chest tube removal on pain and anxiety levels. Eligible adult patients hospitalized in a thoracic surgery unit and scheduled for chest tube removal will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving routine care. Randomization will be performed using a web-based randomization tool to ensure equal allocation.
In the vibration group, a portable vibration device will be applied to the area proximal to the chest tube insertion site for a standardized duration before the removal procedure. In the breathing exercise group, participants will be guided through structured breathing exercises designed to promote relaxation and diaphragmatic breathing. The control group will receive standard clinical care without any additional non-pharmacological intervention.
Pain intensity and anxiety levels will be assessed at two time points: prior to the chest tube removal procedure and shortly after the procedure. Validated measurement tools will be used to ensure reliability of the findings. Data will be analyzed to compare changes in pain and anxiety levels within and between groups.
The results of this study are expected to provide evidence regarding the use of vibration and breathing exercises as simple, safe, and cost-effective nursing interventions to reduce pain and anxiety associated with chest tube removal. These findings may contribute to the development of evidence-based, non-pharmacological strategies in clinical nursing practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gamze BULUT ÖZLÜ
- Phone Number: +905533826019
- Email: gamze.bulut@atauni.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Hospitalized patients with an indwelling chest tube scheduled for removal
- First-time chest tube placement
- Conscious, oriented, and cooperative
- Able to understand and communicate in Turkish
- Hemodynamically stable at the time of chest tube removal
- No use of analgesic or sedative medications within 4 hours prior to the procedure
- Willing and able to provide written informed consent
Exclusion Criteria:
- History of any cognitive or psychiatric disorder
- Previous experience with chest tube placement
- Requirement for mechanical ventilation or endotracheal intubation
- Presence of chronic pain or regular use of analgesic medications
- Use of analgesic or sedative medications immediately before chest tube removal
- Unstable clinical condition at the time of the procedure
- Refusal or inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vibration and Breathing Exercise Group
Participants in this group will receive a combined non-pharmacological intervention consisting of vibration application and guided breathing exercises prior to chest tube removal.
The vibration will be applied using a portable vibration device to the area proximal to the chest tube insertion site for a standardized duration.
Breathing exercises will be performed under the guidance of the researcher and will include slow, deep, and diaphragmatic breathing techniques aimed at promoting relaxation.
All interventions will be administered in addition to routine clinical care.
|
Participants assigned to the intervention group will receive a combined non-pharmacological intervention consisting of vibration application and guided breathing exercises prior to chest tube removal. Vibration will be applied using a portable vibration device placed on the skin near the chest tube insertion site for a standardized duration. The application will be performed while the patient is in a comfortable position. Following the vibration application, participants will be guided through structured breathing exercises, including slow, deep, diaphragmatic, and pursed-lip breathing techniques. These exercises will be conducted by the researcher in a calm and quiet environment to promote relaxation. The combined intervention will be administered in addition to routine clinical care and completed before the chest tube removal procedure. |
|
No Intervention: Control Group (Standard Care)
Participants in the control group will receive routine clinical care according to standard hospital protocols prior to chest tube removal.
No additional non-pharmacological interventions, including vibration or breathing exercises, will be applied before the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Assessed immediately before chest tube removal and 10 minutes after the procedure.
|
Pain intensity associated with chest tube removal will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will self-report their pain level.
|
Assessed immediately before chest tube removal and 10 minutes after the procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Level
Time Frame: Assessed immediately before chest tube removal and 10 minutes after the procedure.
|
Anxiety levels will be measured using the State Anxiety Inventory (State-Trait Anxiety Inventory - State subscale), a validated self-report questionnaire designed to assess situational anxiety.
Higher scores indicate higher levels of anxiety.
|
Assessed immediately before chest tube removal and 10 minutes after the procedure.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Anxiety Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Mechanical Phenomena
- Physical Phenomena
- Breathing Exercises
- Vibration
Other Study ID Numbers
- CTT-VIBREATH-RCT-ATAU-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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