Music for Anxiety in Critically Ill Patients

Anxiety Clinical Trial

— RELACS  

Official title:

Result of a Music Intervention on Anxiety in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796389
• Other study ID #: MEC-2020-0212
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Critical Illness

Intervention

Other:
• Music
Preferred music of the participant administered using headphones.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	South-Holland
Netherlands	Ikazia	Rotterdam	South-Holland
Netherlands	HagaZiekenhuis	The Hague	South-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU length of stay	Measured in total amount of hours spend in the ICU after inclusion.	1.5 year
Other	Mechanical ventilation	Time spend on mechanical ventilation, measured in total amount of hours.	1.5 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ICU memory and experience	Assessed by the ICU memory tool (ICU-MT), difference is assessed per item.	1.5 year
Secondary	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
Secondary	Complications	Complications related to agitation, defined as removal of lines and tube by the patient.	1.5 year
Secondary	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
Secondary	Heart Rate (HR)	Heart Rate at the time of anxiety assessment in beats per minute.	1.5 year
Secondary	Mean Arterial Pressure (MAP)	Mean Arterial Pressure at the time of anxiety assessment in mmHg.	1.5 year