BMJ open · 2025
Study protocol for a multicentre randomised controlled trial using music prehabilitation to reduce preoperative anxiety before oncological colorectal surgery: the MU-PRIOR trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Verhoeven Jorrit Gustav, Geensen Roos, Dirven Thomas Lodewijk Adriaan, Rietdijk Willem Jaap Rogier, Birnie Erwin, Jeekel Johannes, Klimek Markus
Аннотация
INTRODUCTION: Prehabilitation aims to improve preoperative health before surgery to reduce complications. Reducing anxiety helps prevent postoperative pain, stress and sleep disturbances. Listening to music through headphones or earpieces in the hospital directly preoperatively, intraoperatively and postoperatively has been shown to ameliorate anxiety, stress, pain and sleep disorders. This randomised controlled trial will investigate the effect of active music listening at home 1 week before surgery as a prehabilitation modality on preoperative anxiety compared with standard care.
METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial that will include 116 patients. The study population consists of adults undergoing elective oncological colorectal surgery. The intervention group will be advised to listen to recorded music three times per day for 20 min, starting 1 week prior to surgery, using headphones or earpieces. Both groups will receive standard care during hospitalisation. The primary outcome is patient-reported preoperative anxiety using the State-Trait Anxiety IndexInventory 6. Secondary outcomes are patient-reported stress, delirium incidence, medication usage, postoperative pain, complication rate, length of stay, adherence to the intervention, quality of life and healthcare-related costs.
ETHICS AND DISSEMINATION: This study protocol has been approved by the Medical Ethical Review Board of Erasmus Medical Center on 15 December 2022 (MEC-2022-9415). The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. Study results will be published and reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.
TRIAL REGISTRATION NUMBER: NCT05982184.
METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial that will include 116 patients. The study population consists of adults undergoing elective oncological colorectal surgery. The intervention group will be advised to listen to recorded music three times per day for 20 min, starting 1 week prior to surgery, using headphones or earpieces. Both groups will receive standard care during hospitalisation. The primary outcome is patient-reported preoperative anxiety using the State-Trait Anxiety IndexInventory 6. Secondary outcomes are patient-reported stress, delirium incidence, medication usage, postoperative pain, complication rate, length of stay, adherence to the intervention, quality of life and healthcare-related costs.
ETHICS AND DISSEMINATION: This study protocol has been approved by the Medical Ethical Review Board of Erasmus Medical Center on 15 December 2022 (MEC-2022-9415). The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. Study results will be published and reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.
TRIAL REGISTRATION NUMBER: NCT05982184.