Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial

Victor X Fu, Johannes Jeekel, Esther M M Van Lieshout, Detlef Van der Velde, Leonie J P Slegers, Robert Haverlag, Johan Haumann, Marten J Poley, Michael H J Verhofstad, MCHOPIN collaborators, Victor X Fu, Johannes Jeekel, Esther M M Van Lieshout, Detlef Van der Velde, Leonie J P Slegers, Robert Haverlag, Johan Haumann, Marten J Poley, Michael H J Verhofstad, MCHOPIN collaborators

Abstract

Background: Patients undergoing proximal femur fracture surgery are at high risk of postoperative complications, with postoperative delirium occurring in 25%-40% of patients. Delirium has profound effects on patient outcome and recovery, the patient's family, caregivers and medical costs. Perioperative music has a beneficial effect on eliciting modifiable risk factors of delirium. Therefore, the aim of this trial was to evaluate the effect of perioperative recorded music on postoperative delirium in patients with proximal femur fracture undergoing surgery.

Methods and analysis: The Music on Clinical Outcome after Hip Fracture Operations study is an investigator-initiated, multicentre, randomised controlled, open-label, clinical trial. Five hundred and eight patients with proximal femur fracture meeting eligibility criteria will be randomised to the music intervention or control group with concealed allocation in a 1:1 ratio, stratified by hospital site. The perioperative music intervention consists of preselected lists totalling 30 hours of music, allowing participants to choose their preferred music from these lists (classical, jazz and blues, pop and Dutch). The primary outcome measure is postoperative delirium rate. Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality. A 90-day follow-up will be performed in order to assess nursing home length of stay, readmission rate and functional ability to perform daily living activities. Furthermore, the cost and cost-effectiveness of the music intervention will be assessed. Data will be analysed according to an intention-to-treat principle.

Ethics and dissemination: The study protocol has been approved by the Medical Research Ethics Committee Erasmus MC on 8 October 2018 (MEC-2018-110, NL64721.078.18). The trial will be carried out following the Declaration of Helsinki principles, Good Clinical Practice guidelines and Dutch Medical Research Involving Human Subjects Act. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal.

Trial registration number: NTR7036.

Keywords: delirium & cognitive disorders; geriatric medicine; orthopaedic & trauma surgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
MCHOPIN study overview detailing study procedures. The music intervention consists of approximately 30 hours of preselected music divided in four playlists (classical, jazz and blues, pop and Dutch music), allowing patients to choose from these lists. BIS, Bispectral index; DOS, Delirium Observation Screening; DSM-IV, Diagnostic Statistical Manual, Fourth Edition; Katz-ADL6, Six-Item Katz Index of Activities of Daily Living; MCHOPIN, Music on Clinical Outcome after Hip Fracture Operations; NRS, Numerical Rating Scale; POD, Postoperative day; STAI-6, Six-Item State-Trait Anxiety Inventory.

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