- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Altındağ
-
Ankara, Altındağ, Turkije (Türkiye), 06100
- Hacettepe University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Thoracotomy Group
Patients aged 18-75 years who underwent thoracic surgery via thoracotomy and agreed to participate in the study.
|
|
VATS Group
Patients aged 18-75 years who underwent thoracic surgery via video-assisted thoracic surgery and agreed to participate in the study.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Kinesiophobia
Tijdsspanne: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
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.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Functional Capacity
Tijdsspanne: 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
Tijdsspanne: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Pain will be evaluated using the McGill-Melzack Pain Questionnaire, which assesses pain location, quality, temporal characteristics, and intensity.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
|
Dyspnea
Tijdsspanne: Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
Dyspnea severity will be assessed using the Modified Borg Scale, a 0-10 category-ratio scale, with higher scores indicating greater perceived dyspnea.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
|
Fatigue
Tijdsspanne: 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.
|
Early postoperative period, after chest tube removal and before hospital discharge, approximately postoperative days 2-10
|
|
Coronavirus-related Anxiety
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GO 20/1155
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .