Music for Anxiety in Critically Ill Patients (RELACS)

Result of a Music Intervention on Anxiety in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Music

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • South-Holland
    • Rotterdam, South-Holland, Netherlands, 3015 GD
      • Erasmus MC
    • Rotterdam, South-Holland, Netherlands, 3083 AN
      • Ikazia
    • The Hague, South-Holland, Netherlands, 2545 AA
      • Hagaziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Standard of care
EXPERIMENTAL: Recorded music; Recorded music intervention	Other: Music; Preferred music of the participant administered using headphones.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Measured in total amount of hours spend in the ICU after inclusion.	1.5 year
Mechanical ventilation	Time spend on mechanical ventilation, measured in total amount of hours.	1.5 year

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Mathieu Dr. M. van der Jagt, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2020
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (ACTUAL): March 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; anxiety; music; critically ill
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Anxiety Disorders; Critical Illness
• Other Study ID Numbers: MEC-2020-0212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No