Music for Anxiety in Critically Ill Patients

NCT04796389 | Completed

• 1 other identifier: MEC-2020-0212
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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.

Conditions

Anxiety

Keywords

music; anxiety; intensive care unit; critically ill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Anxiety (STAI-6)

  1.5 year

• Sleep quality

  1.5 year

• Delirium

  1 year

• Sedative and opioid medication requirement

  1.5 year

• ICU memory and experience

  1.5 year

Other Outcomes (2)

• ICU length of stay

  1.5 year

• Mechanical ventilation

  1.5 year

Study Arms (2)

Recorded music

EXPERIMENTAL

Recorded music intervention

Other: Music

Control

NO INTERVENTION

Standard of care

Interventions

Music OTHER

Preferred music of the participant administered using headphones.

Recorded music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected ICU stay upon randomisation of at least another 48 hours.
• Written informed consent acquired from the patient or legal representative.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Ikazia

Rotterdam, South Holland, 3083 AN, Netherlands

Location

HagaZiekenhuis

The Hague, South Holland, 2545 AA, Netherlands

Location

Related Publications (2)

• Kakar E, Ottens T, Stads S, Wesselius S, Gommers DAMPJ, Jeekel J, van der Jagt M. Effect of a music intervention on anxiety in adult critically ill patients: a multicenter randomized clinical trial. J Intensive Care. 2023 Aug 17;11(1):36. doi: 10.1186/s40560-023-00684-1.

  PMID: 37592358 DERIVED

• 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.

  PMID: 34642197 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Critical Illness

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mathieu Dr. M. van der Jagt, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 12, 2021
• Study Start: August 24, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)