Music for Anxiety in Critically Ill Patients

Study Overview
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Brief Summary
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Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients. Objective: The primary objective is to assess the effect of music intervention on the level of anxiety. Study design: A randomized controlled trial. Study population: Adult patients admitted to the intensive care unit, with whom communication is possible (Richmond Agitation Sedation Scale of -2 or higher). Intervention (if applicable): The music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. Chosen music will be based on the preference of the patient. The control group will receive standard of care during the entire study. Main study parameters/endpoints: The primary outcome is the effect of music on the Visual Analogue Scale for anxiety (VAS-A). Secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and ICU memory and experience.

Official Title
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Result of a Music Intervention on Anxiety in Critically Ill Patients

Conditions
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Anxiety

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice). Expected ICU stay upon randomisation of at least another 48 hours. Written informed consent acquired from the patient or legal representative. Exclusion Criteria: Patients with severe hearing impairment, defined as no verbal communication possible. Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included). Insufficient knowledge of the Dutch or English language for informed consent. Participation in another study that may possibly intervene with the primary outcome measure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recorded music<br>Recorded music intervention | Other: Music<br>* Preferred music of the participant administered using headphones.<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (VAS-A) | Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means a worse outcome. | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (STAI-6) | Measured using the 6-item State- Trait Anxiety Inventory (STAI-6), on a scale of 20 to 80, in which a higher score means a worse outcome. | 1.5 year | 
| Sleep quality | Measured using a 7-item questionnaire, on a scale of 1 to 7, in which a lower score means a worse outcome. | 1.5 year | 
| Delirium | Measured with the Intensive Care Delirium Screening Checklist (ICDSC), on a scale of 0 to 8, in which a score of 4 or higher indicates delirium. | 1 year | 
| Sedative and opioid medication requirement | Including remifentanyl, propofol, benzodiazepines, dexmedetomidine, clonidine, paracetamol, sufentanyl, fentanyl, morphine, ketamine, epidural analgesia, haloperidol, and other benzodiazepines, atypical anxiolytics and antipsychotics. | 1.5 year | 
| ICU memory and experience | Assessed by the ICU memory tool (ICU-MT), difference is assessed per item. | 1.5 year | 
| Agitation and sedation level | Assessed using the Richmond- Agitation- Sedation Scale (RASS), on a scale of -5 to +4, negative scores indicate level of sedation (a more negative score indicates deeper sedation) and positive scores indicate levels of agitation (the higher the score the more agitated the patient). | 1.5 year | 
| Complications | Complications related to agitation, defined as removal of lines and tube by the patient. | 1.5 year | 
| Level of Pain | Measured using the Critical-Care Pain Observation (CPOT), on a scale of 0 to 8, in mechanically ventilated patients, or the NRS/VAS, on a scale of 0 to 10, for pain in non-ventilated and alert/oriented. | 1.5 year | 
| Heart Rate (HR) | Heart Rate at the time of anxiety assessment in beats per minute. | 1.5 year | 
| Mean Arterial Pressure (MAP) | Mean Arterial Pressure at the time of anxiety assessment in mmHg. | 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, anxiety, intensive care unit, critically ill