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

NCT07624097 | Not Yet Recruiting

• 1 other identifier: CMMC11502-023
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Delirium Confusional State

Outcome Measures

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.

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

Secondary Outcomes (2)

• Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)

  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)

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

Study Arms (3)

Taiwan-localized music group

EXPERIMENTAL

Other: Taiwan-localized music Listening Combined With Mindful Breathing

Classical music group

EXPERIMENTAL

Other: Classical music Listening Combined With Mindful Breathing

Control group

NO INTERVENTION

Control group

Interventions

Taiwan-localized music Listening Combined With Mindful Breathing OTHER

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

Taiwan-localized music group

Classical music Listening Combined With Mindful Breathing OTHER

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

Classical music group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Chimei Medical Center: lead

MeSH Terms

Conditions

Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): April 9, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05