About this trial
Delirium is the most common and severe neuropsychiatric complication in the Intensive Care Unit (ICU), with an incidence as high as 87% in the United States, 75.6% in medical ICUs in Taiwan, and 41.7% in surgical ICUs, with patients developing delirium an average of 2.6 days after admission. Delirium is associated with prolonged mechanical ventilation, increased complications, higher in-hospital mortality, greater psychological burden on family members, and elevated clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions for delirium prevention, among which music intervention has emerged as one of the most promising strategies due to its low risk, low cost, and feasibility in the ICU setting. Although several international studies have supported its potential benefits, evidence remains inconclusive. Mindfulness-based approaches represent another non-pharmacological strategy that intentionally directs attention to present-moment bodily sensations; mindful breathing exercises are particularly suitable for ICU patients, as they only require patients to adopt a comfortable position in bed and focus on each inhalation and exhalation under guidance, quickly restoring awareness to present bodily experience. Incorporating mindful breathing before and after music listening may therefore facilitate emotional regulation and present-moment awareness, enhancing patient engagement and attentional focus during the intervention. Existing delirium prevention studies in Taiwan have predominantly employed multicomponent care bundles, leaving a gap in empirical evidence regarding music as a standalone intervention. Moreover, scholars have highlighted that musical preference and cultural background influence patients' psychological responses to music, underscoring the importance of cultural appropriateness. In response to this gap, the present study proposes a music intervention combining classical music and Taiwan-localized music with mindful breathing exercises, aiming to examine the effects on ICU delirium incidence and severity, compare the effectiveness of classical versus Taiwan-localized music, and explore the potential benefits on patient anxiety and pain, with the hope of providing a culturally informed, evidence-based music repertoire to guide clinical practice in Taiwan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 20 years or older who can communicate verbally or in writing
Able to receive music therapy
Pain score > 2 within the past 24 hours
Delirium prediction model risk > 20%
Disqualifiers
Positive delirium screening at ICU admission
Significant hearing impairment
Inability to cooperate with wearing over-the-ear headphones
Trial design
Parallel
Treatments tested in this trial
Taiwan-localized music Listening Combined With Mindful Breathing
Other interventionParticipants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
Classical music Listening Combined With Mindful Breathing
Other interventionParticipants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of delirium assessed by CAM-ICU-7
Delirium severity will be measured using the Confusion Assessment Method for the ICU 7-item scale (CAM-ICU-7). The total score ranges from 0 to 7, with higher scores indicating greater delirium severity. Measurements will be taken twice daily (at 09:00 and 17:00) during the 5-day intervention period.
Secondary outcomes
Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)
The Critical-Care Pain Observation Tool (CPOT) will be used to assess pain behavioral indicators in ICU patients. The tool includes four domains: facial expression, body movements, muscle tension, and compliance with the ventilator (or vocalization for extubated patients). The total score ranges from 0 to 8, with higher scores indicating a higher level of pain intensity.
Anxiety level assessed by the Faces Anxiety Scale (FAS)
The Faces Anxiety Scale (FAS) will be used to measure the self-reported anxiety level of ICU patients. The scale consists of 5 faces showing progressive levels of anxiety. The total score ranges from 0 (no anxiety) to 4 (severe anxiety), with higher scores indicating a higher level of anxiety.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: