Dataset Information

Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial.

ABSTRACT:

Background

Previous studies show positive effect of music on reducing anxiety, pain, and medication requirement. Anxiety has become a more pertinent issue in the intensive care unit (ICU) since wakefulness is preferred according to recent guidelines. Nevertheless, evidence on the effect of music in ICU patients is scarce. Therefore, we studied the effect of music intervention on anxiety in ICU patients.

Methods

A multicenter randomized clinical trial was conducted between August 2020 and December 2021 in ICU's at an academic medical centre and two regional hospitals. Adult critically ill patients were eligible when hemodynamically stable and able to communicate (Richmond agitation-sedation scale (RASS) of at least - 2). Patients in the intervention arm were offered music twice daily during three days for at least 30 min per session. Patients in the control group received standard care. The primary outcome was anxiety level assessed with the visual analogue scale for anxiety [VAS-A; range 0-10] twice daily (morning and evening). Secondary outcomes included; 6-item state-trait anxiety inventory (STAI-6), sleep quality, delirium, heart rate, mean arterial pressure, pain, RASS, medication, ICU length of stay, patients' memory and experience of ICU stay.

Results

94 patients were included in the primary analysis. Music did not significantly reduce anxiety (VAS-A in the intervention group; 2.5 (IQR 1.0-4.5), 1.8 (0.0-3.6), and 2.5 (0.0-3.6) on day 1, 2, and 3 vs. 3.0 (0.6-4.0), 1.5 (0.0-4.0), and 2.0 (0.0-4.0) in the control group; p > 0.92). Overall median daily VAS-A scores ranged from 1.5 to 3.0. Fewer patients required opioids (21 vs. 29, p = 0.03) and sleep quality was lower in the music group on study day one [5.0 (4.0-6.0) vs. 4.5 (3.0-5.0), p = 0.03]. Other outcomes were similar between groups.

Conclusions

Anxiety levels in this ICU population were low, and music during 3 days did not decrease anxiety. This study indicates that efficacy of music is context and intervention-dependent, given previous evidence showing decreased anxiety. Trial registration Netherlands Trial Register: NL8595, Registered, 1 April 2020.

Clinicaltrials

gov ID: NCT04796389, Registered retrospectively, 12 March 2021.

SUBMITTER: Kakar E

PROVIDER: S-EPMC10433648 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial.

Kakar Ellaha E Ottens Thomas T Stads Susanne S Wesselius Sanne S Gommers Diederik A M P J DAMPJ Jeekel Johannes J van der Jagt Mathieu M

Journal of intensive care 20230817 1

<h4>Background</h4>Previous studies show positive effect of music on reducing anxiety, pain, and medication requirement. Anxiety has become a more pertinent issue in the intensive care unit (ICU) since wakefulness is preferred according to recent guidelines. Nevertheless, evidence on the effect of music in ICU patients is scarce. Therefore, we studied the effect of music intervention on anxiety in ICU patients.<h4>Methods</h4>A multicenter randomized clinical trial was conducted between August 2 ...[more]

PMID: 37592358

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Project description:IntroductionAnxiety 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 designA 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 disseminationThe 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 numberNCT04796389.

Project description:ImportanceAlternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support.ObjectiveTo test whether listening to self-initiated patient-directed music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients.Design, setting, and patientsRandomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the Minneapolis-St Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days.InterventionsSelf-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125).Main outcomes and measuresDaily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency).ResultsPatients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median [range], 12 [0-796]) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median [range], 0 [0-916]) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, -32.2 to -6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by -0.18 (95% CI, -0.36 to -0.004) points/day (P = .05) and had reduced frequency by -0.21 (95% CI, -0.37 to -0.05) points/day (P = .01). The PDM group had reduced sedation frequency by -0.18 (95% CI, -0.36 to -0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity.Conclusions and relevanceAmong ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH.Trial registrationclinicaltrials.gov Identifier: NCT00440700.

Project description:BackgroundStress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied.MethodsThe Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children.DiscussionDespite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention.Trial registrationThe study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.

Project description:ObjectiveSleep 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.DesignSystematic review and meta-analysis.Data sourcesEmbase, MEDLINE Ovid, Cochrane Central, Web of Science and Google Scholar.Eligibility criteria for studiesRandomised controlled trials assessing the effect of music on sleep quality in critically ill and surgical patients.MethodsThe 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.ResultsFive 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.ConclusionsRecorded 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 numberCRD42020167783.

Dataset Information

Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial.

Background

Methods

Results

Conclusions

Clinicaltrials

Publications

Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial.

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