Music to Prevent Delirium: A Prospective, Randomized, Controlled, Three-Arm Parallel-Group Clinical Trial in an Argentine Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Days Alive and Free of Delirium and Coma
研究概览
简要总结
The goal of this clinical trial is to learn if listening to music can prevent delirium in older adults admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are:
- Does listening to music increase the number of days participants are alive and free of delirium and coma during a 7-day period?
- Is personalized music more effective than generic relaxing music?
Researchers will compare Personalized Music and Relaxing Music to Standard Care (no study-provided music) to see if the music intervention improves delirium outcomes compared to usual care.
Participants will:
- Listen to music through headphones twice daily (morning and afternoon) for at least 30 minutes during a 7-day period (intervention groups).
- Receive standard ICU care and undergo daily assessments for delirium and level of consciousness.
详细描述
BACKGROUND AND RATIONALE Delirium is a prevalent form of acute brain dysfunction in the Intensive Care Unit (ICU), affecting a significant proportion of older critically ill adults, including those receiving invasive mechanical ventilation. It is independently associated with increased mortality, long-term cognitive impairment, and higher healthcare costs. Current pharmacological strategies for delirium prevention have limited efficacy; consequently, clinical guidelines recommend multicomponent non-pharmacological interventions. This study aims to evaluate the clinical effectiveness of a structured music listening intervention as a preventive strategy in older ICU patients.
STUDY DESIGN AND SETTING This study is a single-center, prospective, randomized, controlled trial with three parallel groups conducted in the mixed medical-surgical Intensive Care Unit (27 beds) at the Hospital Británico de Buenos Aires, Argentina.
RECRUITMENT AND RANDOMIZATION Patients admitted to the ICU are screened daily. To ensure inclusion of high-acuity patients (including those receiving invasive mechanical ventilation), screening continues until the patient becomes evaluable. The recruitment window opens during the first 24 hours after the patient first achieves an adequate level of consciousness (RASS -2 to +2) and is confirmed CAM-ICU negative. Randomization must occur within 24 hours of the patient first becoming evaluable and no later than 120 hours (5 days) from ICU admission. Patients who are CAM-ICU positive are not eligible for randomization. Patients who do not become evaluable within 120 hours of ICU admission are not eligible. Allocation is managed via a secure, web-based automated randomization module (REDCap) hosted on the Hospital Británico server. To ensure allocation concealment, the sequence is generated by an independent statistician using permuted blocks of random sizes and loaded into the system. The assignment is revealed to the investigator only after the participant's baseline data has been entered into the system.
INTERVENTION PROTOCOL The protocol consists of music sessions scheduled twice daily in two predefined time windows (Morning: 08:00-12:00; Afternoon: 14:00-20:00) to allow controlled delivery without interfering with ICU care. Each session lasts at least 30 minutes for up to 7 days after randomization, and the first session is started ideally within 2 hours (maximum 4 hours) after randomization unless clinically contraindicated or delayed by procedures. All protocolized sessions are delivered exclusively using study-provided MP3 players and circumaural headphones to ensure technical standardization. Outside the protocolized sessions, participants may listen to additional music using either study equipment or personal devices, with source and minutes recorded separately. Research staff perform a visual check 15 minutes into each session to support protocol fidelity. Sessions may end before 30 minutes if delirium develops (e.g., agitation) or at the participant's request. Study staff ensure that the volume is comfortable and not excessively loud (approximately equivalent to normal conversation, 60-70 dB). Headphones and MP3 players undergo cleaning/disinfection per institutional Infection Control standards between patients. Minutes of total music exposure are recorded daily. In the Relaxing Music arm, any listening that is not consistent with the assigned relaxing-music intervention is recorded as a protocol deviation ("contamination"), with minutes documented. Personalized Music (MP): Playlists are curated based on the participant's prior music preferences (songs provided for loading onto the study MP3 player) and aim to evoke positive emotions. Relaxing Music (MR): Standardized playlists feature slow-tempo (60-80 bpm) instrumental tracks without lyrics. Intervention delivery and daily outcome assessment cease at the earliest of day 7, documented ICU transfer order, death, or withdrawal of consent.
CONTROL GROUP AND STANDARD OF CARE The Control arm receives the institutional standard of care for delirium prevention (ABCDEF Bundle). Importantly, this standard of care is provided to all study participants regardless of group assignment. To preserve the integrity of the comparison, Control participants and families are asked to avoid using music devices during the fixed 7-day study window; however, music is not actively prohibited if the patient requests it or uses personal equipment. Any such exposure is recorded as a protocol deviation ("contamination"), including duration (minutes) and type of exposure. Television or spoken-word radio (e.g., news, podcasts) is allowed as part of usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention (music via headphones), blinding of participants and care providers is not feasible. However, the Outcome Assessor responsible for the daily CAM-ICU and RASS evaluation is blinded to group assignment. To ensure blinding, music devices are not present in the patient's room during the assessment and intervention delivery is recorded in separate study forms (CRFs) rather than the routine medical chart to prevent unblinding via chart review.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older.
- •Negative Confusion Assessment Method for the ICU (CAM-ICU) at the time of randomization.
- •Expected ICU length of stay of at least 48 hours based on clinical judgement at admission (e.g., need for mechanical ventilation, vasopressors, invasive monitoring).
排除标准
- •Positive CAM-ICU prior to randomization.
- •Acute primary Central Nervous System pathology (e.g., ischemic or hemorrhagic stroke, traumatic brain injury, meningoencephalitis, intracranial hypertension) presenting with altered sensorium (Glasgow Coma Scale at admission < 14) or focal deficit preventing cognitive assessment (e.g., severe aphasia).
- •Severe chronic cognitive impairment or advanced dementia, defined by a known history of severe functional dependence prior to admission (requiring permanent assistance for basic activities of daily living such as feeding or grooming)
- •Unresolved auditory or visual impairment.
- •Suspected or confirmed intoxication with drugs or alcohol at admission.
- •Uncontrolled psychiatric disease (at least one acute episode requiring intervention in the last 6 months).
- •Richmond Agitation-Sedation Scale (RASS) score < -2 or > +2 at the time of randomization.
- •Medical condition precluding the safe use of headphones (e.g., burns, skull fracture, skin lesions).
- •Inability to establish effective communication due to a language disorder or unresolved language barrier.
- •Inability of the patient or legal representative to provide informed consent.
- •Patients with imminent death, end-of-life care, or limitation of therapeutic effort.
研究组 & 干预措施
Control
Patients receive the institutional Standard of Care (ABCDEF Bundle) for delirium prevention. Participants and families are asked to avoid the use of music devices during the fixed 7-day study window; however, music use is not actively prohibited if requested by the patient or occurs using personal devices. Any such exposure is recorded as protocol deviation ("contamination"), including estimated duration (minutes), source, and type of exposure.
干预措施: Standard of Care (Other)
Relaxing Music
In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of standardized, slow-tempo (60-80 bpm) instrumental tracks without lyrics.
干预措施: Relaxing Music (Other)
Relaxing Music
In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of standardized, slow-tempo (60-80 bpm) instrumental tracks without lyrics.
干预措施: Standard of Care (Other)
Personalized Music
In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of songs selected by the patient or proxy based on personal preferences to evoke positive emotions.
干预措施: Personalized Music (Other)
Personalized Music
In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of songs selected by the patient or proxy based on personal preferences to evoke positive emotions.
干预措施: Standard of Care (Other)
结局指标
主要结局
Days Alive and Free of Delirium and Coma
时间窗: From randomization up to Day 7
Number of days alive and free of delirium and coma (range 0-7) in a fixed 7-day window (Day 1 = calendar day of randomization). Coma is defined as a Richmond Agitation-Sedation Scale (RASS) score of -3 to -5 (scale range: +4 \[combative\] to -5 \[unarousable\]). Delirium is defined as the presence of delirium assessed by the Confusion Assessment Method for the ICU (CAM-ICU) or by a positive chart review (screening nursing notes for delirium-related keywords); CAM-ICU is not assessed during coma. Assessments are performed daily. A day is "free" only if the patient is alive, has RASS ≥ -2, and is delirium-negative on both CAM-ICU and chart review. ICU discharge order (transfer order) before Day 7: remaining days counted free. Death before Day 7: remaining days counted non-free. Higher values indicate better outcomes.
次要结局
- Days with Delirium(From randomization up to Day 7)
- Days with Coma(From randomization up to Day 7)
- Incidence of Delirium(From randomization up to Day 7)
- Mortality During Intervention(From randomization up to Day 7)
- Intensive Care Unit Length of Stay(From ICU admission to physical ICU discharge, assessed up to 90 days)
- Cumulative Antipsychotic Load(From randomization up to Day 7)
- Cumulative Benzodiazepine Load(From randomization up to Day 7)
- Cumulative Dexmedetomidine Load(From randomization up to Day 7)
- Cumulative Opioid Load(From randomization up to Day 7)
- Cumulative Propofol Load(From randomization up to Day 7)
- Change in Anxiety Level(From randomization up to Day 7 (assessed twice daily))
- Days with Physical Restraints(From randomization up to Day 7)
- Time to Successful Extubation(From randomization until successful extubation, assessed up to ICU discharge or Day 90, whichever occurs first)
- Ventilator-Free Days at Day 28(From randomization up to Day 28)
研究者
Sebastián Consalvo
Principal Investigator
HOSPITAL BRITANICO DE BUENOS AIRES