Music
OtherPreferred music of the participant administered using headphones.
NCT Number: NCT04796389
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Erasmus MC, Rotterdam, South Holland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preferred music of the participant administered using headphones.
Time frame: 1.5 year
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.
Time frame: 1.5 year
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.
Time frame: 1.5 year
Measured using a 7-item questionnaire, on a scale of 1 to 7, in which a lower score means a worse outcome.
Time frame: 1 year
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.
Time frame: 1.5 year
Including remifentanyl, propofol, benzodiazepines, dexmedetomidine, clonidine, paracetamol, sufentanyl, fentanyl, morphine, ketamine, epidural analgesia, haloperidol, and other benzodiazepines, atypical anxiolytics and antipsychotics.
Time frame: 1.5 year
Assessed by the ICU memory tool (ICU-MT), difference is assessed per item.
Time frame: 1.5 year
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).
Time frame: 1.5 year
Complications related to agitation, defined as removal of lines and tube by the patient.
Time frame: 1.5 year
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.
Time frame: 1.5 year
Heart Rate at the time of anxiety assessment in beats per minute.
Time frame: 1.5 year
Mean Arterial Pressure at the time of anxiety assessment in mmHg.
Time frame: 1.5 year
Measured in total amount of hours spend in the ICU after inclusion.
Time frame: 1.5 year
Time spend on mechanical ventilation, measured in total amount of hours.
Erasmus Medical Center
Other
Result of a Music Intervention on Anxiety in Critically Ill Patients
Acronym: RELACS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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