Clinical trial NCT04796389: Music for Anxiety in Critically Ill Patients
Official title: Result of a Music Intervention on Anxiety in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: music
anxiety
intensive care unit
critically ill
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety (VAS-A)
timeFrame: 1.5 year
Secondary outcomes:
measure: Anxiety (STAI-6)
timeFrame: 1.5 year
measure: Sleep quality
timeFrame: 1.5 year
measure: Delirium
timeFrame: 1 year
measure: Sedative and opioid medication requirement
timeFrame: 1.5 year
measure: ICU memory and experience
timeFrame: 1.5 year
measure: Agitation and sedation level
timeFrame: 1.5 year
measure: Complications
timeFrame: 1.5 year
measure: Level of Pain
timeFrame: 1.5 year
measure: Heart Rate (HR)
timeFrame: 1.5 year
measure: Mean Arterial Pressure (MAP)
timeFrame: 1.5 year
Other outcomes:
measure: ICU length of stay
timeFrame: 1.5 year
measure: Mechanical ventilation
timeFrame: 1.5 year
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: South-Holland
city: Rotterdam
country: Netherlands
facility: Ikazia
state: South-Holland
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
state: South-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Mathieu Dr. M. van der Jagt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kakar E, Van Mol M, Jeekel J, Gommers D, van der Jagt M. Study protocol for a multicentre randomised controlled trial studying the effect of a music intervention on anxiety in adult critically ill patients (The RELACS trial). BMJ Open. 2021 Oct 12;11(10):e051473. doi: 10.1136/bmjopen-2021-051473.