- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07935330
Effect of Extended Reality-Supported Exercise Training on Shoulder Pain, Range of Motion, Pulmonary Function, Quality of Recovery, and Adherence to the Exercise Program in Patients Undergoing Thoracic Surgery
Effect of Extended Reality-Supported Exercise Training on Shoulder Pain, Range of Motion, Pulmonary Function, Quality of Recovery, and Adherence to the Exercise Program in Patients Undergoing Thoracic Surgery: Randomized Controlled Trial
The present study aims to determine the effects of an XR-supported exercise education video developed for patients undergoing thoracic surgery on shoulder pain, range of motion (ROM), pulmonary function, quality of recovery, and adherence to the exercise program. This study is designed as a prospective, two-arm (1:1), randomized controlled clinical trial. The study population will consist of patients undergoing thoracic surgery at the Thoracic Surgery Clinic of Mersin University Hospital between October 2026 and October 2027. As shoulder pain is the primary outcome of the study, the sample size calculation was based on the study by Reeve et al. (2010). According to the a priori power analysis performed using G*Power version 3.1, assuming a significance level of ? = 0.05, 95% statistical power (1?ß), and a two-tailed hypothesis, the required total sample size was calculated to be 54 patients. Considering a potential attrition rate of 10%, the target sample size was increased to 60 patients (30 in the XR-supported exercise education group and 30 in the control group). Data will be collected using the Patient Information Form, Visual Analog Scale (VAS), Range of Motion Assessment Form, Pulmonary Function Test Parameters Follow-up Form, Quality of Recovery-40 Questionnaire (QoR-40), and the Exercise Follow-up Form. Upon hospital admission, all participants will complete the Patient Information Form, Visual Analog Scale, Range of Motion Assessment Form, and Pulmonary Function Test Parameters Follow-up Form. Patients assigned to the intervention group will receive XR-supported exercise education before thoracic surgery, whereas those in the control group will receive the routine education provided in the clinic (consisting of verbal instruction and standard face-to-face patient education with demonstration). Participants in both the intervention and control groups will be assessed on postoperative days 7 and 14 using the Visual Analog Scale, Range of Motion Assessment Form, Pulmonary Function Test Parameters Follow-up Form, and the Quality of Recovery40 Questionnaire. During hospitalization, adherence to the prescribed exercise program will be monitored using the Exercise Follow-up Form based on patients' self-reports.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Following thoracic surgery, patients commonly experience several clinical problems during the recovery period, including pain related to improper positioning, the surgical incision and/or thoracic drain, inability to perform effective coughing, decreased lung capacity, development of postoperative pulmonary complications, inadequate airway clearance, restricted shoulder range of motion on the operated side, postural abnormalities, and persistent chest wall tightness. These complications adversely affect patients' quality of recovery. To prevent these complications, exercise training as part of perioperative pulmonary rehabilitation plays a key role. One of the innovative and contemporary approaches that can be incorporated into patient education is extended reality (XR) technology. A systematic and comprehensive review of the international and national literature revealed that although studies have investigated structured and standardized exercise education for patients undergoing thoracic surgery, research evaluating XR-supported exercise education remains limited. The present study aims to determine the effects of an XR-supported exercise education video developed for patients undergoing thoracic surgery on shoulder pain, range of motion (ROM), pulmonary function, quality of recovery, and adherence to the exercise program. This study is designed as a prospective, two-arm (1:1), randomized controlled clinical trial. The study population will consist of patients undergoing thoracic surgery at the Thoracic Surgery Clinic of Mersin University Hospital between October 2026 and October 2027. As shoulder pain is the primary outcome of the study, the sample size calculation was based on the study by Reeve et al. (2010). According to the a priori power analysis performed using G*Power version 3.1, assuming a significance level of ? = 0.05, 95% statistical power (1?ß), and a two-tailed hypothesis, the required total sample size was calculated to be 54 patients. Considering a potential attrition rate of 10%, the target sample size was increased to 60 patients (30 in the XR-supported exercise education group and 30 in the control group). Data will be collected using the Patient Information Form, Visual Analog Scale (VAS), Range of Motion Assessment Form, Pulmonary Function Test Parameters Follow-up Form, Quality of Recovery-40 Questionnaire (QoR-40), and the Exercise Follow-up Form. Upon hospital admission, all participants will complete the Patient Information Form, Visual Analog Scale, Range of Motion Assessment Form, and Pulmonary Function Test Parameters Follow-up Form. Patients assigned to the intervention group will receive XR-supported exercise education before thoracic surgery, whereas those in the control group will receive the routine education provided in the clinic (consisting of verbal instruction and standard face-to-face patient education with demonstration). Participants in both the intervention and control groups will be assessed on postoperative days 7 and 14 using the Visual Analog Scale, Range of Motion Assessment Form, Pulmonary Function Test Parameters Follow-up Form, and the Quality of Recovery40 Questionnaire. During hospitalization, adherence to the prescribed exercise program will be monitored using the Exercise Follow-up Form based on patients' self-reports. Descriptive characteristics of the participants will be presented as mean ± standard deviation, median (minimum maximum), frequency, and percentage. After assessing the normality of data distribution, continuous variables with normal distribution will be compared between the two independent groups using the independent samples t-test. Continuous variables that do not follow a normal distribution will be analyzed using the Mann Whitney U test. Statistical significance will be accepted at p 0.05 with a 95% confidence interval. The study findings are expected to be published in an SCI-Expanded (Q1) journal and presented as an abstract at an international scientific congress. The innovative XR-supported educational approach developed for patients undergoing thoracic surgery is expected to improve patient outcomes and treatment adherence while reducing healthcare costs.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: GÜLAY ALTUN UĞRAŞ
- Telefonszám: 03246000033
- E-mail: gulaltun@mersin.edu.tr
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: GAMZE BOZKUL
Tanulmányi helyek
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Mersin, Törökország (Türkiye), 33400
- Mersin Unıversıty
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Kapcsolatba lépni:
- Gamze Bozkul
- E-mail: gamze.bozkul@gmail.com
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Kapcsolatba lépni:
- E-mail: gamze.bozkul@gmail.com
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Alkutató:
- Gamze Bozkul
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Kutatásvezető:
- Gülay ALTUN UĞRAŞ
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Patients who have undergone thoracic surgery (wedge resection, pneumonectomy, lobectomy, or segmentectomy),
- Patients who have provided written informed consent to participate in the study,
- Patients who are literate,
- Patients aged 18 years or older,
- Patients who are hemodynamically stable and eligible for mobilization,
- Patients who are at least 24-48 hours postoperatively and have been permitted to undergo early mobilization,
- Patients with adequate visual and auditory abilities,
- Patients without any mental or cognitive disorders,
- Patients who can communicate in Turkish and understand instructions,
- Patients with no previous experience using virtual reality (VR) headsets.
Exclusion Criteria:
- Patients who do not wish to participate in the study,
- Patients with preoperative shoulder joint movement limitations, contractures, deficits, or similar conditions.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Experimental group
Patients in the intervention group will receive XR-supported exercise training before thoracic surgery |
Extended reality-supported exercise training will be taught after the patient is admitted to the thoracic surgery clinic before surgery (one day before the operation). Under the supervision of the researchers, patients will perform the exercises daily throughout their hospital stay. Each supervised exercise session will be conducted in accordance with a standardized training protocol. Starting from postoperative day 0, diaphragmatic breathing and pursed-lip breathing exercises will be performed for 8-10 repetitions daily. Shoulder range of motion (ROM) exercises will be initiated on postoperative day 1 and performed for 10-12 repetitions in 3 sets. In addition to the researcher-supervised sessions, patients will be instructed to perform diaphragmatic breathing and pursed-lip breathing exercises approximately every two hours while awake, and shoulder ROM exercises three times a day until postoperative day 14. |
|
Nincs beavatkozás: Control group
Control group will receive standard patient education as part of the clinic's routine care practices, consisting of face-to-face verbal information and face-to-face demonstrations provided by healthcare professionals. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Postoperative Pain
Időkeret: 7months
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Visual Analog Scale (VAS): This scale is a horizontal line that allows patients to subjectively rate their pain intensity on a scale ranging from 0 (no pain) to 10 (worst possible pain). It will be used to assess patients' postoperative pain levels. |
7months
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Joint Range of Motion
Időkeret: 7 months
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Joint Range of Motion (ROM) Assessment Form: The patient's ROM will be assessed at the beginning of the study and at the end of the exercise training intervention using an electronic digital inclinometer purchased through the project budget. |
7 months
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Pulmonary Function Test FVC (L)
Időkeret: 7 months
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Pulmonary Function Test (PFT) Parameters Monitoring Form: The patient's pulmonary function tests (PFTs) will be measured immediately after performing the exercises using the "Portable Digital Spirometer" (CONTEC SP80b, Contec Medical Systems Co., Ltd., China), which belongs to the principal investigator (G.A.U.).During the assessment, the FVC (L) parameters will be recorded in the Pulmonary Function Test Parameters Monitoring Form. |
7 months
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Quality of Recovery
Időkeret: 7 months
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Quality of Recovery-40 Questionnaire (QoR-40): This scale was developed by Myles et al to assess the quality of recovery following anesthesia and surgery. |
7 months
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Pulmonary Function Test FEV1 (L)
Időkeret: 7 months
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Pulmonary Function Test (PFT) Parameters Monitoring Form: The patient's pulmonary function tests (PFTs) will be measured immediately after performing the exercises using the "Portable Digital Spirometer" (CONTEC SP80b, Contec Medical Systems Co., Ltd., China), which belongs to the principal investigator (G.A.U.).During the assessment, the FEV1 (L) parameters will be recorded in the Pulmonary Function Test Parameters Monitoring Form. |
7 months
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Pulmonary Function Test FEV1/FVC (%)
Időkeret: 7 months
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Pulmonary Function Test (PFT) Parameters Monitoring Form: The patient's pulmonary function tests (PFTs) will be measured immediately after performing the exercises using the "Portable Digital Spirometer" (CONTEC SP80b, Contec Medical Systems Co., Ltd., China), which belongs to the principal investigator (G.A.U.).During the assessment, the FEV1/FVC (%) parameters will be recorded in the Pulmonary Function Test Parameters Monitoring Form. |
7 months
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Gülay altun uğraş, Mersin University
Publikációk és hasznos linkek
Általános kiadványok
- Andrews C, Southworth MK, Silva JNA, Silva JR. Extended Reality in Medical Practice. Curr Treat Options Cardiovasc Med. 2019 Mar 30;21(4):18. doi: 10.1007/s11936-019-0722-7.
- Ahmad AM. Essentials of Physiotherapy after Thoracic Surgery: What Physiotherapists Need to Know. A Narrative Review. Korean J Thorac Cardiovasc Surg. 2018 Oct;51(5):293-307. doi: 10.5090/kjtcs.2018.51.5.293. Epub 2018 Oct 5.
- Abd El Monem Beltagy, W., Said Taha, A., & Ali Ibrahim, R. (2022). Effect of inspiratory muscle training program on health outcomes among patients with thoracic surgery. Journal of Nursing Science Benha University, 3(2), 75-91. https://doi.org/10.21608/ jnsbu.2022.244323
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TU-BOZKUL-022
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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