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Music Timing for Emergence Delirium in Elderly

The Differences Between the Effects of Intraoperative vs Postoperative Preferred Music on Emergence Agitation or Delirium in Elderly Patients: A Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06970249
Enrollment
400
Registered
2025-05-14
Start date
2025-05-15
Completion date
2025-06-05
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium on Emergence, Elderly, Satisfaction, Patient

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.

Interventions

BEHAVIORALMusic 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.

Sponsors

Wonkwang University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the incidence of emergence delirium (ED)will be assessed every 15 minutes and during staying in the Postanesthesia care unit (PACU)wil be defined as a Richmond Agitation-Sedation Scale (RASS) score ≥+1 within 60 minutes after extubation.

Secondary

MeasureTime frameDescription
The severity of emrgence delirium (ED)within 60 minutes in the PACUhighest RASS score
The duration of EDwithin 60 minutes in the PACUminutes from extubation to RASS ≤ 0
Postoperative painwill be assessed every 15 minutes and during staying in the Postanesthesia care unit (PACU)visual analogue scale (VAS, 0-10)
Patients satisfactionWhen patients leave from PACU.5-point Likert scale, 1 = very dissatisfied, 5 = very satisfied,
preoperative anxietythe day before the operationthe State-Trait Anxiety Inventory (STAI-S, 20-80, with 10 positively worded items reverse-scored).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026