- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07647822
Comparison of Early Postoperative Functional Capacity and Kinesiophobia in Patients Undergoing Thoracic Surgery Via Thoracotomy or VATS
Comparison of Early Postoperative Functional Capacity, Kinesiophobia, Pain, Dyspnea, Fatigue, and Anxiety in Patients Undergoing Thoracic Surgery Via Thoracotomy or Video-Assisted Thoracic Surgery
This observational cross-sectional study aims to compare early postoperative functional capacity and kinesiophobia in patients undergoing thoracic surgery via thoracotomy or video-assisted thoracic surgery (VATS). Patients aged 18-75 years who underwent thoracic surgery and agreed to participate will be evaluated during the early postoperative period, after chest tube removal and before hospital discharge.
Functional capacity will be assessed using the 1-minute sit-to-stand test. Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia. Pain, dyspnea, fatigue, and coronavirus-related anxiety will also be assessed using validated scales and questionnaires. The study will investigate the relationship between kinesiophobia and postoperative functional and symptom-related outcomes.
Study Overview
Status
Conditions
Detailed Description
Thoracic surgical procedures may lead to postoperative pain, reduced mobility, impaired functional capacity, and fear of movement. Thoracotomy involves opening the chest wall and is associated with greater surgical trauma, whereas video-assisted thoracic surgery (VATS) is a minimally invasive surgical approach performed through smaller incisions without rib spreading. VATS is generally associated with lower morbidity, shorter hospital stay, and earlier return to physical activity.
Kinesiophobia, defined as an excessive and irrational fear of movement or re-injury, may negatively affect postoperative recovery and rehabilitation participation. Although kinesiophobia has been widely investigated in musculoskeletal and chronic pain conditions, there is limited evidence regarding its role after thoracic surgery.
The aim of this study is to evaluate early postoperative functional capacity, kinesiophobia, and factors associated with kinesiophobia in patients undergoing thoracic surgery via thoracotomy or VATS. Eligible patients will be assessed in the early postoperative period, after removal of chest tubes and before discharge, corresponding approximately to postoperative days 2-10.
Demographic and clinical data will be recorded. Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia. Functional capacity will be evaluated using the 1-minute sit-to-stand test. Pain will be assessed using the McGill-Melzack Pain Questionnaire. Dyspnea and fatigue will be evaluated using the Modified Borg Scale. Coronavirus-related anxiety will be assessed using the Coronavirus Anxiety Scale Short Form.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Altındağ
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Ankara, Altındağ, Turkey (Türkiye), 06100
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Undergoing thoracic surgery via thoracotomy or video-assisted thoracic surgery
- Aged between 18 and 75 years
- Volunteering to participate in the study
- Providing informed consent
Exclusion Criteria:
- Presence of cooperation or communication problems that prevent assessment
- History of previous thoracic surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Thoracotomy Group
Patients aged 18-75 years who underwent thoracic surgery via thoracotomy and agreed to participate in the study.
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VATS Group
Patients aged 18-75 years who underwent thoracic surgery via video-assisted thoracic surgery and agreed to participate in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
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Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia.
The scale consists of 17 items scored on a 4-point Likert scale.
Total scores range from 17 to 68, with higher scores indicating greater fear of movement.
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Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Capacity
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Functional capacity will be assessed using the 1-minute sit-to-stand test.
The number of full sit-to-stand repetitions completed in one minute will be recorded.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
|
Pain Level
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
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Pain will be evaluated using the McGill-Melzack Pain Questionnaire, which assesses pain location, quality, temporal characteristics, and intensity.
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Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
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Dyspnea
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
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Dyspnea severity will be assessed using the Modified Borg Scale, a 0-10 category-ratio scale, with higher scores indicating greater perceived dyspnea.
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Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
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Fatigue
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Fatigue severity will be assessed using the Modified Borg Scale, a 0-10 category-ratio scale, with higher scores indicating greater perceived fatigue.
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Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
|
Coronavirus-related Anxiety
Time Frame: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Coronavirus-related anxiety will be assessed using the Coronavirus Anxiety Scale Short Form.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
Other Study ID Numbers
- GO 20/1155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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