Music Intervention for rEduction of Preoperative Anxiety and Prevention of Postoperative deLirium in Older aDults Undergoing Cardiac surgerY
| Registry | NCT07851194, acronym MELODY |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 256 (Estimated) |
| Sponsor | KU Leuven (Other) |
| Conditions | Postoperative Delirium, Preoperative Anxiety, Cardiac Surgery |
| Interventions | Music Intervention Group (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-03-28 (estimated), completion 2028-04-15 (estimated), first posted 2026-10-01, last updated 2026-10-01 |
| Locations | 1 site in Belgium |
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All trials for Postoperative Delirium All trials for Preoperative Anxiety All trials of Music Intervention Group
The goal of this clinical trial is to evaluate the effectiveness of the music intervention in preventing postoperative delirium (POD) in older patients undergoing elective cardiac surgery.
The primary question is: Among older adults undergoing elective cardiac surgery, does offering a structured perioperative music intervention in addition to standard care reduce the incidence of POD within the first five postoperative days compared with standard care alone? The secondary questions are: Does perioperative music intervention reduce preoperative anxiety (PA) among older patients undergoing cardiac surgery, and does the level of PA moderate the effect of the music intervention on POD?
Researchers will compare music intervention to routine care to see if music intervention can reduce PA and prevent POD.
Participants will listen to music before and after surgery, be assessed for PA and POD, and participate in an interview about participants' perspectives on the music intervention.
Background:
Postoperative delirium (POD) is a common and serious complication among older patients undergoing cardiac surgery. POD is characterized by an acute and fluctuating disturbance in attention and cognition and is associated with prolonged hospital stays, increased morbidity and mortality, functional decline, and substantial healthcare costs. Although various preventive strategies have been investigated, POD remains a major challenge in perioperative care. An important but often underestimated risk factor is preoperative anxiety (PA), which affects approximately half of patients undergoing cardiac surgery. PA is associated with increased psychological stress and greater requirements for anesthetic agents and postoperative analgesics, factors that may in turn increase the risk of POD. Reducing PA is therefore considered a promising strategy for POD prevention.
As pharmacological treatments for anxiety and delirium may be associated with adverse effects, particularly in older and vulnerable patients, there is growing interest in non-pharmacological interventions. Music intervention is particularly attractive because of the favorable safety profile, low cost, ease of implementation, and high patient acceptability. Although previous studies suggest that music may reduce preoperative anxiety and potentially have a beneficial effect on the prevention of POD, the findings remain inconclusive, and many studies have methodological limitations. Moreover, other relevant outcomes, such as delirium severity, postoperative pain, and cost-effectiveness, have often been insufficiently investigated.
Therefore, a prospective, single-center, randomized controlled trial will be conducted among older patients undergoing elective cardiac surgery at University Hospitals Leuven. A total of 256 patients will be enrolled and randomly assigned to either an intervention group or a control group. In addition to standard care, participants in the intervention group will receive a structured perioperative music intervention delivered via headphones and smartphones, whereas participants in the control group will receive standard care alone.
The primary aim of this study is to evaluate the effectiveness of a music intervention in preventing postoperative delirium. The occurrence of POD during the first five postoperative days will be assessed using validated delirium assessment tools, including the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM), the Chart-based Delirium Identification Instrument (CHART-DEL), and the Delirium Observation Screening Scale (DOSS). In addition, the study will investigate the effects of the music intervention on preoperative anxiety, POD severity, postoperative pain, perioperative medication use, anesthetic requirements, intraoperative hemodynamic parameters, postoperative complications, and length of hospital stay. Exploratory analyses will also examine the potential role of preoperative anxiety in the relationship between the music intervention and the occurrence of POD.
Primary objective:
To determine whether a structured perioperative music intervention in addition to standard care reduces the incidence of POD within the first five postoperative days among older adults undergoing elective cardiac surgery, compared with standard care alone.
Secondary objective:
1. To evaluate the effects of the structured perioperative music intervention on other clinically relevant perioperative and postoperative outcomes, including PA, POD severity, perioperative medication use, anesthetic drug dosage, postoperative pain, postoperative complications, and length of hospital stay.
2. To explore whether baseline PA and changes in PA during the preoperative period are associated with the incidence of POD.
Setting: This clinical trial will be conducted in the Department of Cardiovascular Surgery of the University Hospitals Leuven.
Overall methodology:
This study is a prospective, single-center, two-arm, parallel-group randomized controlled trial (RCT).
A total of 256 participants aged ≥65 years undergoing elective cardiac surgery will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a centralized, computer-generated randomization procedure implemented through Research Electronic Data Capture (REDCap). Randomization will be performed after eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed. The allocation sequence will be generated using variable block sizes and concealed from personnel involved in participant recruitment and trial conduct until allocation.
Participants in the intervention group will receive a structured perioperative music intervention in addition to standard perioperative care. The intervention consists of approximately eight music-listening sessions of 20-30 minutes each, delivered through headphones and smartphones from the evening before surgery through postoperative day 5 or until hospital discharge, whichever occurs first. Participants will be able to select music according to participant preferences from standardized playlists developed for the study. Participants in the control group will receive standard perioperative care without the study music intervention. Non-study music exposure will be documented in both groups to assess potential contamination.
The study will follow an open-label design because blinding of participants, intervention providers, clinical staff, and outcome assessors is not feasible given the nature of the intervention. To minimize potential bias, study procedures and outcome assessments will be standardized, and statistical analyses will be conducted by a statistician blinded to treatment allocation.
The primary outcome is the incidence of POD within the first five postoperative days. Secondary outcomes include preoperative anxiety, POD severity, delirium subtypes, perioperative medication use, anesthetic drug dosage for induction and maintenance, intraoperative hemodynamic variables, postoperative pain, postoperative complications, and length of hospital stay.
The primary outcome will be analyzed in the Full Analysis Set (FAS) using robust Poisson regression with an identity link to estimate the treatment effect and 95% confidence interval, with randomized treatment group as the primary model factor. Sensitivity analyses will adjust for prespecified baseline covariates, including age, sex, baseline cognitive status, type of surgery, and habitual music-listening behavior, and will also be conducted using the Secondary Estimand and the Per-Protocol Set (PPS). Secondary analyses of the primary outcome will include time-to-event analyses using Kaplan-Meier methods and Cox regression. Binary secondary outcomes will be analyzed using robust Poisson regression, and repeated continuous outcomes will primarily be analyzed using constrained longitudinal data analysis (cLDA). Length of hospital stay will be analyzed as time to live discharge, with in-hospital death treated as a competing risk. Prespecified exploratory subgroup analyses will examine treatment-effect heterogeneity by age, type of surgery, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), habitual music listening, and baseline preoperative anxiety using treatment-by-subgroup interaction terms. Exploratory analyses will also assess associations between baseline preoperative anxiety, changes in preoperative anxiety, and postoperative delirium incidence. All randomized participants will be included in the primary estimand analyses regardless of treatment completion or follow-up status. Missing outcome data will primarily be handled using multiple imputation under the Missing At Random assumption, with sensitivity analyses conducted where appropriate. Treatment effects will be interpreted based on effect estimates, 95% confidence intervals, and clinical relevance.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Music intervention group | Experimental | Other: Music Intervention Group | Participants in the intervention group will receive eight perioperative music sessions in addition to standard care. Each session will last approximately 20-30 minutes. Two sessions will be provided preoperatively (on the evening before surgery and on the morning of surgery), followed by six postoperative sessions (one in the recovery room and one daily from postoperative day 1 to day 5). Music will be delivered via smartphones and wireless headphones using participant-selected playlists on Spotify. A trained research nurse will provide instructions and assistance with the equipment. The number and duration of completed music sessions will be documented. |
| Routine care | No intervention | Participants in the control group will receive standard perioperative care without any music intervention. Any active or passive music listening will be documented, including the timing and type of music. |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * Voluntary written informed consent of the participant or the participant's legally authorized representative has been obtained prior to any screening procedures * At least 65 years of age at the time of signing the Informed Consent Form (ICF) * Scheduled for elective cardiac surgery. * Able to participate and communicate in Dutch. Exclusion Criteria: * Participant has a history of music-induced seizures. * Inability to use headphones or smartphones. * Deafness or severe hearing impairment, defined as being unable to listen to music. * Presence of delirium at baseline, as screened with the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). * Disabling neurological diseases, including stroke, dementia, and active epilepsy (requiring ongoing anti-epileptic medication). * Current treatment with anxiolytics, antidepressants, or antipsychotics. * Admission on the day of surgery. * Expected postoperative intensive care unit (ICU) admission longer than one day. * Participation in an interventional study with an investigational medicinal product (IMP) or device.
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Leuven | Leuven, Vlaams-Brabant | Belgium |