Music Timing for Emergence Delirium in Elderly

NCT06970249 | Completed DMC

• 1 other identifier: Wonkwang UH18
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence delirium (ED) after general anesthesia prolongs recovery, increases complications, and adds to nursing workload in elderly patients. Although music has been shown to alleviate anxiety and agitation, the optimal timing for its delivery and the factors that predict its effectiveness remain unclear. This trial will compare preferred music played during surgery versus music played after surgery to see how each affects the incidence, the severity, and the duration of ED in older adults, and to identify which patient characteristics predict ED.

Conditions

Delirium on Emergence; Elderly; Satisfaction, Patient

Outcome Measures

Primary Outcomes (1)

• the incidence of emergence delirium (ED)

  wil be defined as a Richmond Agitation-Sedation Scale (RASS) score ≥+1 within 60 minutes after extubation.

  will be assessed every 15 minutes and during staying in the Postanesthesia care unit (PACU)

Secondary Outcomes (5)

• The severity of emrgence delirium (ED)

  within 60 minutes in the PACU

• The duration of ED

  within 60 minutes in the PACU

• Postoperative pain

  will be assessed every 15 minutes and during staying in the Postanesthesia care unit (PACU)

• Patients satisfaction

  When patients leave from PACU.

• preoperative anxiety

  the day before the operation

Study Arms (3)

Control

NO INTERVENTION

The control group received standard care with ambient sounds.

Intraoperative

ACTIVE COMPARATOR

Patient-preferred music (e.g., classical, jazz, ambient) will be selected preoperatively from a standardized list and delivered via headphones at 40-60 dB, will be verified by a sound meter. Intraoperative music will run from induction to extubation

Behavioral: Music intervention

Postoperative

ACTIVE COMPARATOR

Patient-preferred music (e.g., classical, jazz, ambient) will be selected preoperatively from a standardized list and delivered via headphones at 40-60 dB, will be verified by a sound meter. Postoperative music will be provided for 60 minutes after extubation in the PACU.

Behavioral: Music intervention

Interventions

Music intervention BEHAVIORAL

Patient-preferred music (e.g., classical, jazz, ambient) will be selected preoperatively from a standardized list and delivered via headphones at 40-60 dB, verified by a sound meter.

Intraoperative; Postoperative

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• All participants will have a Mini-Mental State Examination (MMSE) score of 20 or higher and no significant hearing impairment.

You may not qualify if:

• Investigators will exclude patients undergoing emergency procedures, those with severe psychiatric illness, MMSE below 20, or any condition preventing informed consent.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

Location

Related Publications (1)

• Golubovic J, Neerland BE, Aune D, Baker FA. Music Interventions and Delirium in Adults: A Systematic Literature Review and Meta-Analysis. Brain Sci. 2022 Apr 28;12(5):568. doi: 10.3390/brainsci12050568.

  PMID: 35624955 RESULT

MeSH Terms

Conditions

Emergence Delirium; Patient Satisfaction

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Cheol Lee, M.D.,Ph.D

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: "Outcome assessors (PACU nurses) will be blinded to group allocation. Participants, care providers, and investigators will not be blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patient-preferred music (e.g., classical, jazz, ambient) will be selected preoperatively from a standardized list and delivered via headphones at 40-60 dB, verified by a sound meter. 1. Intraoperative music will be played from induction to extubation; 2. Postoperative music will be provided for 60 minutes following extubation in the PACU. 3. The control group will receive standard care with ambient sounds.

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: May 15, 2025
• Primary Completion: May 25, 2025
• Study Completion: June 5, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)