- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07624097
Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Kontrolgruppe
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Eksperimentel: Taiwan-localized music group
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Participants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
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Eksperimentel: Classical music group
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Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence and severity of delirium assessed by CAM-ICU-7
Tidsramme: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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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.
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Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)
Tidsramme: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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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.
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Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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Anxiety level assessed by the Faces Anxiety Scale (FAS)
Tidsramme: Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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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.
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Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMMC11502-023
Plan for individuelle deltagerdata (IPD)
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