NCT06531928

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

May 28, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Chest tube withdrawalPainAnxietyVideo-assisted thoracoscopic surgeryVATS

Outcome Measures

Primary Outcomes (1)

  • visual analog scale -Anxiety

    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 Outcomes (1)

  • visual analog scale-Pain

    24 hours

Interventions

The Effect of Chest Tube Withdrawal on Patients' Anxiety Levels in Thoracic Surgery Cases Performed with Video-Assisted Thoracoscopic Surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Ramazan Baldemir, Specialist

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor

Study Record Dates

First Submitted

May 28, 2024

First Posted

August 1, 2024

Study Start

August 15, 2024

Primary Completion

June 15, 2025

Study Completion

July 30, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations