Implementation of music in the perioperative standard care of colorectal surgery: study protocol of the IMPROVE Study.

INTRODUCTION: Perioperative music intervention has been proven effective in reducing anxiety, pain, neurohormonal stress response and medication requirement. Unfortunately, there is a gap between new effective interventions and their (interventions) integration in standard care protocols. The aim of this preimplementation and postimplementation study is to investigate the adherence to a music intervention in a tailored, multilevel, systematic implementation strategy and the initial impact of the implementation on postoperative pain in patients undergoing colorectal surgery. METHODS AND DESIGN: A monocentre prospective preimplementation and postimplementation study was set up using The Consolidated Framework for Implementation Research to conduct a systematic implementation of music intervention in three phases. Primary outcomes are adherence to the music intervention and the initial impact of the music intervention implementation on postoperative pain scores on the first postoperative day. At least 100 patients will be included in the study. Secondary outcomes include adherence to the implementation strategy, penetration of music intervention in the standard care, assessment of the determinants for implementation, impact of the implemented music intervention on pain during the entire admission, anxiety, medication usage, complications, hospital and intensive care unit (ICU) length of stay. ETHICS AND DISSEMINATION: The Medical Ethics Review Board of Erasmus MC University Medical Centre Rotterdam, The Netherlands, has approved this protocol. The study is being conducted in accordance with the Declaration of Helsinki. Results of this trial will be published in peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION: Dutch Trial Register NL8071.

Study protocol for a multicentre randomised controlled trial studying the effect of a music intervention on anxiety in adult critically ill patients (The RELACS trial).

INTRODUCTION: Anxiety is common in critically ill patients and has likely become more prevalent in the recent decade due to the imperative of the recent Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients (PADIS) to use low levels of sedation and strive for wakefulness. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation. Sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimised. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients. METHODS AND DESIGN: A multicentre randomised controlled trial was designed to study the effect of a music intervention on the level of anxiety experienced by adult patients admitted to the intensive care unit (ICU). One hundred and four patients will be included in three centres in the Netherlands. Patient recruitment started on 24-08-2020 and is ongoing in three hospitals. The primary outcome is self-reported anxiety measured on the visual analogue scale. Secondary outcomes include anxiety measured using the six-item State-Trait Anxiety Inventory, sleep quality, agitation and sedation level, medication requirement, pain, delirium, complications, time spend on mechanical ventilation, physical parameters and ICU memory and experience. ETHICS AND DISSEMINATION: The Medical Ethics Review Board of Erasmus MC University Medical Centre Rotterdam, The Netherlands, has approved this protocol. The study is being conducted in accordance with the Declaration of Helsinki. Results of this trial will be published in peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT04796389.

Music intervention for sleep quality in critically ill and surgical patients: a meta-analysis.

OBJECTIVE: Sleep disruption occurs frequently in hospitalised patients. Given the potential of music intervention as a non-pharmacological measure to improve sleep quality, we aimed to assess and quantify current literature on the effect of recorded music interventions on sleep quality and quantity in the adult critical care and surgical populations. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Embase, MEDLINE Ovid, Cochrane Central, Web of Science and Google Scholar. ELIGIBILITY CRITERIA FOR STUDIES: Randomised controlled trials assessing the effect of music on sleep quality in critically ill and surgical patients. METHODS: The electronic databases were systematically searched from 1 January 1981 to 27 January 2020. Data were screened, extracted and appraised by two independent reviewers. Primary outcomes were sleep quality and quantity, assessed with validated tools. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Random effects meta-analysis was performed, and pooled standardised mean differences (SMDs) with 95% CIs were reported. RESULTS: Five studies (259 patients) were included in qualitative (risk of bias) and quantitative analysis (meta-analysis). Pooled data showed a significant effect of recorded music on subjective sleep quality in the critical care and surgical population (SMD=1.21 (95% CI 0.50 to 1.91), p<0.01, excluding one non-English study; SMD=0.87 (95% CI 0.45 to 1.29), p<0.01). The SMD of 1.21 corresponded to a 27.1% (95% CI 11.2 to 42.8) increase in subjective sleep quality using validated questionnaires. A significant increase in subjective sleep quantity of 36 min was found in one study. Objective measurements of sleep assessed in one study using polysomnography showed significant increase in deeper sleep stage in the music group. CONCLUSIONS: Recorded music showed a significant improvement in subjective sleep quality in some critical care and surgical populations. Therefore, its use may be relevant to improve sleep, but given the moderate potential for bias, further research is needed. PROSPERO REGISTRATION NUMBER: CRD42020167783.

Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis.

OBJECTIVES: Previous studies have reported beneficial effects of perioperative music on patients' anxiety and pain. We performed a systematic review and meta-analysis of randomised controlled trials investigating music interventions in cardiac surgery. METHODS: Five electronic databases were systematically searched. Primary outcomes were patients' postoperative anxiety and pain. Secondary outcomes were hospital length of stay, opioid use, vital parameters and time on mechanical ventilation. PRISMA guidelines were followed and PROSPERO database registration was completed (CRD42020149733). A meta-analysis was performed using random effects models and pooled standardised mean differences (SMD) with 95% confidence intervals were calculated. RESULTS: Twenty studies were included for qualitative analysis (1169 patients) and 16 (987 patients) for meta-analysis. The first postoperative music session was associated with significantly reduced postoperative anxiety (SMD = -0.50 (95% CI -0.67 to -0.32), p<0.01) and pain (SMD = -0.51 (95% CI -0.84 to -0.19), p<0.01). This is equal to a reduction of 4.00 points (95% CI 2.56 to 5.36) and 1.05 points (95% CI 0.67 to 1.41) on the State-Trait Anxiety Inventory and Visual Analogue Scale (VAS)/Numeric Rating Scale (NRS), respectively, for anxiety, and 1.26 points (95% CI 0.47 to 2.07) on the VAS/NRS for pain. Multiple days of music intervention reduced anxiety until 8 days postoperatively (SMD = -0.39 (95% CI -0.64 to -0.15), p<0.01). CONCLUSIONS: Offering recorded music is associated with a significant reduction in postoperative anxiety and pain in cardiac surgery. Unlike pharmacological interventions, music is without side effects so is promising in this population.