- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07624097
Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollgrupp
|
|
|
Experimentell: Taiwan-localized music group
|
Participants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
|
|
Experimentell: Classical music group
|
Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence and severity of delirium assessed by CAM-ICU-7
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)
Tidsram: 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)
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CMMC11502-023
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .