Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients

Overview

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.

Detailed description

Delirium is the most common and severe neuropsychiatric symptom occurring in Intensive Care Units (ICUs). Research in the United States indicates that the incidence of ICU delirium can reach as high as 87%. In Taiwan, the incidence rate is 75.6% in medical ICUs and 41.7% in surgical ICUs. On average, patients develop delirium 2.6 days after admission. Delirium not only negatively impacts patients-leading to prolonged mechanical ventilation, increased complications, and higher hospital mortality rates-but also increases the physical and mental burden on family members and the clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions to prevent delirium. Among these interventions, music is considered one of the most promising approaches because it is low risk, low cost, and easy to implement in the ICU setting. Several international studies have supported the potential benefits of music listening for delirium prevention; however, the effectiveness of such interventions remains inconclusive. Mindfulness is another non-pharmacological strategy that intentionally redirects attention to present-moment bodily sensations. Among various mindfulness practices, mindful breathing exercises are particularly suitable for ICU patients. Patients only need to adopt a comfortable position in bed and, under guidance, focus their attention on each inhalation and exhalation, which can quickly bring their awareness back to the present sensations of the body. Incorporating mindful breathing exercises into the procedures before and after music listening may serve as an adjunct to facilitate emotional regulation and awareness of present-moment experience, thereby enhancing patients' engagement and attentional focus during the music-listening context.

In Taiwan, existing studies on delirium prevention have mainly employed multicomponent care bundles, and empirical evidence on music as a single intervention remains lacking. Given that scholars at home and abroad have indicated that musical preference and national culture influence patients' psychological responses to music, and in view of the aforementioned research gap as well as clinical feasibility and utility, this study proposes to use classical music and Taiwan-localized music as intervention modalities, combined with mindful breathing exercises before and after music listening. The study will examine the effects of different types of music on the occurrence and severity of delirium, and further compare the intervention effectiveness of classical versus Taiwan-localized music, as well as explore their potential benefits for anxiety and pain. It is hoped that this work will fill the current gap in research on music-based interventions for ICU patients with delirium in Taiwan and provide an evidence-based repertoire of music selections for clinical practice.

Interventions

• Other Taiwan-localized music Listening Combined With Mindful Breathing
  Participants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
• Other Classical music Listening Combined With Mindful Breathing
  Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.

Primary outcome measures

• Incidence and severity of delirium assessed by CAM-ICU-7 [Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)]

Secondary outcome measures (2)

• Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT) [Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)]
• Anxiety level assessed by the Faces Anxiety Scale (FAS) [Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)]

Eligibility criteria

Inclusion criteria

• 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%

Exclusion criteria

• Positive delirium screening at ICU admission
• Significant hearing impairment
• Inability to cooperate with wearing over-the-ear headphones

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07624097 · CMMC11502-023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗