Result of music intervention on anxiety in critically ill patient.

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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Music is not associated with any known risks. Music volume will be limited to avoid hearing damage. Most of the outcome measures are already included in routine care of the ICU. We estimate a high potential for benefit with no potential for harm, given the previous literature on this topic.

We hypothesize that music intervention can have a positive effect on anxiety in critically ill patients and aim to study the effect of music intervention in these patients.

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Recorded music