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

31 mei 2026 bijgewerkt door: Chimei Medical Center
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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

51

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Controlegroep
Experimenteel: Taiwan-localized music group
Participants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
Experimenteel: Classical music group
Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and severity of delirium assessed by CAM-ICU-7
Tijdsspanne: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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.
Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)
Tijdsspanne: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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.
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)
Tijdsspanne: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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.
Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 oktober 2026

Studie voltooiing (Geschat)

9 april 2027

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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