Music Timing for Emergence Delirium in Elderly

NCT ID: NCT06970249

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-06-05

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.

Detailed Description

Study Design and Participants This prospective, single-blind, randomized controlled trial will be conducted following approval by the Institutional Review Board of Wonkwang University Hospital (IRB No. [2025-04-021-0045]). Written informed consent will be obtained from all participants. The study will adhere to the 2013 Declaration of Helsinki.

The investigators will enroll adults aged 65 years or older with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective surgery lasting 1-3 hours under general anesthesia. All participants will have a Mini-Mental State Examination (MMSE) score of 20 or higher and no significant hearing impairment. Patients undergoing emergency procedures, those with severe psychiatric illness, an MMSE score below 20, or any condition preventing informed consent will be excluded.

Randomization and Blinding A computer-generated random sequence will be created using Stata 17.0 (StataCorp, College Station, TX, USA), employing block randomization stratified by age group (65-75 vs. >75 years), sex, and surgery type. Allocation to one of three groups-intraoperative music, postoperative music, or control-will be concealed in sealed, opaque envelopes. PACU nurses assessing outcomes will remain blinded; anesthesiologists and PACU staff administering music interventions will not participate in data collection.

Interventions General anesthesia will be induced with propofol (2 mg/kg), maintained with sevoflurane (BIS 40-60), and supplemented with remifentanil (0.05-0.2 µg/kg/min). No benzodiazepine premedication will be administered. 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 music will be played from induction to extubation; postoperative music will be provided for 60 minutes following extubation in the PACU. The control group will receive standard care with ambient sounds. Intraoperative hypotension (mean arterial pressure <20% of baseline) will be treated with ephedrine (5-10 mg), and postoperative pain will be managed with fentanyl (0.5 µg/kg) as needed.

Outcome Measures The primary outcome will be the incidence of ED, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥+1 within 60 minutes after extubation, assessed every 15 minutes by two trained PACU nurses (expected inter-rater κ = 0.85). Secondary outcomes will include severity of ED (highest RASS score within 60 minutes), duration of ED (minutes from extubation to RASS ≤ 0), postoperative pain (VAS, 0-10, assessed every 15 minutes for 60 minutes), patient satisfaction (5-point Likert scale, 1 = very dissatisfied, 5 = very satisfied, at PACU discharge), adverse events (including incidence of nausea, vomiting, respiratory depression, and other complications), and preoperative anxiety.

Preoperative anxiety will be measured using the State-Trait Anxiety Inventory (STAI-S); scores range from 20 to 80, with higher scores indicating greater anxiety (including 10 reverse-scored items). All data will be recorded using a standardative outcomes.ized Case Report Form, encompassing demographic information, MMSE scores, anesthetic details, and postoperative outcomes.

Conditions

Delirium on Emergence; Elderly; Satisfaction, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

The control group received standard care with ambient sounds.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intraoperative

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

Group Type: ACTIVE_COMPARATOR

Music intervention

Intervention Type: 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.

Postoperative

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.

Group Type: ACTIVE_COMPARATOR

Music intervention

Intervention Type: 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.

Interventions

Music intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wonkwang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheol Lee,MD,PhD,

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheol Lee, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Locations

Wonkwag UH

Iksan, Jeollabukdo, South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 35624955 (View on PubMed)

Other Identifiers

Wonkwang UH18

Identifier Type: -

Identifier Source: org_study_id