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ID
Source
Brief title
Health condition
Intensive Care Unit
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire immediately after each music session during three consecutive days after inclusion.
Secondary outcome
- Anxiety: measured using the 6-item short version State -Trait Anxiety Inventory (STAI-6) questionnaire immediately after each music session during three consecutive days after inclusion.
- Agitation and sedation level: measured using the Richmond Agitations- Sedation Scale (RASS), assessed three times daily during every shift, as long as the patient is mechanically ventilated and/or sedated as part of the standard care procedure.
- Medication requirement (duration and dosages, corrected for body weight milligram/killogram), including remifenanyl, propofol, benzodiazepines, dexmedetomidine, clonidin, paracetamol, sufentanyl, fentanyl, morphine, ketamine, epidural analgesia, haloperidol, and other benzodiazepines, atypical anxiolytics and antipsychotics.
- Pain: measured using the Critical Pain Observation Tool (CPOT) in mechanically ventilated patients, or the NRS/VAS for pain in non-ventilated and alert/oriented as part of the standard care procedure.
- Sleep quality: assessed daily in the morning after awakening, starting before the music session at baseline, and during the intervention period. Sleep will be assessed using a visual numeric scale ranging from one to seven, in which one indicates “did not/barely sleep” and seven indicates: “slept very well”
- Delirium: measured with the Intensive Care Delirium Screening Checklist (ICDSC), which is routinely done in all ICU patients, three times daily, as part of the standard care procedure.
- ICU memory and experience: assessed by the ICU memory tool (ICU-MT) extended with self-made questions to assess ICU experience, once at the end of the study period.
- Complications related to agitation: defined as removal of lines and tube (auto-detubation) by the patient.
- Time spend on mechanical ventilation: measured in total amount of hours.
- ICU length of stay (LOS): measured in total amount of hours spend in the ICU after inclusion.
- Physical parameters: daily heart rate (HR), and arterial blood pressure (MAP) at the time when the primary outcome (anxiety) is assessed during the intervention period will be collected and analysed, in order to gain insight in proxy-measures for stress level.
- Patient memory and experience: assessed by the ICU memory tool (ICUMT) extended with self-made questions to assess ICU experience. We adapted and shortened the ICUMT to a seven-item questionnaire to avoid overlap, e.g. with assessment of anxiety or delirium, and with other tools, and to avoid invasive long questionnaires. For the patient experience assessment in the music group the questionnaire is extended with five items and for the control group with three items.
Background 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.
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.
Study objective
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.
Study design
NA
Intervention
Recorded music
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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8595 |
| Other | METC Erasmus MC : MEC-2020-0212 |