- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531928
Effect of Chest Tube Withdrawal on Patients' Anxiety Levels After Thoracic Surgery
January 8, 2025 updated by: Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
The Effect of Chest Tube Withdrawal on Patients' Anxiety Levels After Video-Assisted Thoracoscopic Surgery
Since the removal of the chest tube is a painful procedure, it can cause serious anxiety in patients.
Patients state that chest tube removal is among the bad memories they experience.
The source of the anxiety may be related to fear and anxiety about the pain caused by the upcoming chest tube removal procedure, or it may be the words they have heard from other patients who have had this experience before.
There are a limited number of studies in the literature on anxiety that may occur in patients due to chest tube withdrawal.
In addition, studies in the literature did not focus on whether there was a difference between pre-procedure and post-procedure anxiety levels.
In this study, it was aimed to investigate the anxiety levels before and after the procedure and the pain levels felt in the patients due to the procedure due to chest tube withdrawal in patients who underwent VATS.
In addition, it aimed to investigate whether there is any correlation between pre-procedure anxiety and pain experienced during the procedure.
If a correlation is detected, the importance of pre-procedural anxiety management will be better understood, the necessity of interventions such as psychological and pharmacological treatment for anxiety will come to the fore, and new research on this subject will be needed.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ramazan Baldemir, Specialist
- Phone Number: +905303570166
- Email: baldemir23@yahoo.com
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey, 06290
- Recruiting
- Ankara Ataturk Sanatorium Training and Research Hospital
-
Contact:
- Ramazan Baldemir, Specialist
- Phone Number: +905303570166
- Email: baldemir23@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients between the ages of 18-65, those with a BMI between 18-35 kg/m2, patients who have undergone VATS, patients who have a single chest tube inserted during surgery, patients who have undergone resection with VATS (wedge resection, segmentectomy, lobectomy) will be included in the study.
Description
Inclusion Criteria:
- The ages of 18-65
- BMI between 18-35 kg/m2
- Who have undergone VATS
- Who have a single chest tube inserted during surgery
- who have undergone resection with VATS (wedge resection, segmentectomy, lobectomy)
Exclusion Criteria:
- Who have undergone surgery under emergency conditions,
- Who have undergone thoracotomy, decortication, pleural biopsy,
- Who constantly use anti-inflammatory or analgesic drugs,
- Patients with preoperative chronic pain,
- Who have undergone thoracic surgery before,
- Patients with a history of chest tube insertion and for any reason after surgery (prolonged air leakage),
- Patients whose chest tube has not been removed for more than 7 days,
- Who have undergone pleurodesis
- Patients with psychiatric diagnoses or who use psychiatric drugs
- Who are illiterate will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale -Anxiety
Time Frame: 24 hours
|
Investigation of pre-procedure and post-procedure anxiety levels due to chest tube removal in patients undergoing VATS and pain felt by patients due to the procedure.
The VAS-anxiety is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-100 mm) that best reflects the intensity of his anxiety.
It is considered a one-dimensional measure of anxiety intensity in adults.
It ranges from "0 mm" representing no anxiety to "100 mm" representing extreme anxiety.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale-Pain
Time Frame: 24 hours
|
It was aimed to investigate whether there is any correlation between pre-procedure anxiety and pain experienced during the procedure.
The VAS-pain is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-100 mm) that best reflects the intensity of his pain.
It is considered a one-dimensional measure of pain intensity in adults.
It ranges from "0 mm" representing no pain to "100 mm" representing extreme pain.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2024
Primary Completion (Estimated)
June 15, 2025
Study Completion (Estimated)
July 30, 2025
Study Registration Dates
First Submitted
May 28, 2024
First Submitted That Met QC Criteria
July 30, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 8, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024-BCEK/61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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