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Not yet recruitingNCT07624097Updated Jun 3, 2026

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

An interventional study of Taiwan-localized music Listening Combined With Mindful Breathing and Classical music Listening Combined With Mindful Breathing in Delirium Confusional State, sponsored by Chimei Medical Center. Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Chimei Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Delirium Confusional State

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In context

Confusion

88 studies on the registry are indexed under Confusion; 19 are open to participants now.

This study's planned enrollment of 51 is below the median of 115 across 56 interventional studies indexed under Confusion.

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Lead sponsor

Chimei Medical Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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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

Exclusion Criteria:

  • Positive delirium screening at ICU admission
  • Significant hearing impairment
  • Inability to cooperate with wearing over-the-ear headphones
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Taiwan-localized music group

    Other: Taiwan-localized music Listening Combined With Mindful Breathing

  • Experimental
    Classical music group

    Other: Classical music Listening Combined With Mindful Breathing

  • No intervention
    Control group

    Control group

Interventions

  • OtherTaiwan-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.

  • OtherClassical music Listening Combined With Mindful Breathing

    Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

Secondary outcomes

  1. 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.

    Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

  2. 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.

    Time frame: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07624097
Lead sponsor
Chimei Medical Center
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Apr 9, 2027 (estimated)
Last update
Jun 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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