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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

12 november 2026 uppdaterad av: Gamze BOZKUL, Tarsus University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: GAMZE BOZKUL

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain
Tidsram: 7months

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
Joint Range of Motion
Tidsram: 7 months

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
Pulmonary Function Test FVC (L)
Tidsram: 7 months

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
Quality of Recovery
Tidsram: 7 months

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
Pulmonary Function Test FEV1 (L)
Tidsram: 7 months

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
Pulmonary Function Test FEV1/FVC (%)
Tidsram: 7 months

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Gülay altun uğraş, Mersin University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 december 2026

Primärt slutförande (Beräknad)

15 juni 2027

Avslutad studie (Beräknad)

15 december 2027

Studieregistreringsdatum

Först inskickad

7 november 2026

Först inskickad som uppfyllde QC-kriterierna

12 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TU-BOZKUL-022

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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