- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Altındağ
-
Ankara, Altındağ, Tyrkia (Türkiye), 06100
- Hacettepe University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Kinesiophobia
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GO 20/1155
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Thorakotomi
-
Menoufia UniversityFullført
-
Denizhan AcarFullførtThoracotomy analgesiTyrkia (Türkiye)
-
Nguyen Dang ThuVietnam National Children's HospitalFullførtPostoperativ smerte | Thoraxkirurgisk lunge | Regional anestesi | Thoracotomy analgesiVietnam
-
Cairo UniversityRekrutteringParavertebral blokk | Thorax epidural anestesi | Våken thoracotomyEgypt