Clinical trial NCT04401514: Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit
Official title: Does ROCKING Chairs Calm Delirious Patients in the Intensive Care Unit: a Multicenter Clinical Randomized Trial (RockingICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Lead sponsor: Scandinavian Critical Care Trials Group
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Delirium among patients admitted to an ICU is a common condition associated with increased morbidity and mortality. To this point no evidence-based prevention or treatment exist for delirium. Non-pharmacological interventions such as early mobilization and systematic bundle of care have been suggested to decrease the number of days of delirium. So far there exist no studies exploring if delirious patients benefit or not when mobilized to a rocking chair with music therapy.

Objectives: To assess if rocking chair therapy can decrease the burden of delirium in adult, critical ill patients admitted to an ICU.

Design: A clinical initiated multicenter randomized non-blinded trial, of delirious patients mobilized to a rocking chair versus no rocking chair.

Inclusion and exclusion criteria: Inclusion criteria: Adult intensive care patients (18 years and above) diagnosed with delirium with a validated screening tool. Exclusion criteria: if the patient is evaluated not to be mobilized to a rocking chair and expressing discomfort and do not wish to be mobilized, a patient with critical illness neuropati, patients with lever coma, patient in ECM treatment, patients that are mentally permanently incompetent, not receiving active life support if needed, weight more that 130 kg, if informed consent cannot be obtained, if the patient is admitted because of suicide attempt and is the patient have delirium tremens.

Intervention: The experimental intervention is a 20 min. long rocking chair with music therapy. Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on. Standardized pharmacological and non-pharmacological interventions for delirium will continue for both groups. Delirium and consciousness will be evaluated twice a day.

Outcomes: Primary outcome: number of days alive without coma and delirium in the ICU. Secondary outcome: Number of days admitted to the ICU and number of patients with at least one difference in RASS score before end after the experimental intervention.

Trial size: A power calculation have estimated that a total number of 76 patients with delirium should be included in each study group.

Time schedule: We estimate that the inclusion period and follow up will as long as 1 year from the time the first patient is randomized.

Amendment's protocol Agreed by the project group August 22nd 2022, we will do an additional 90-day follow-up of all-cause mortality. This was agreed before the project group or statistician had access to the randomisation key and intervention data, and before any statistical analysis was started.

Detailed description: The intervention is a 30 min long transfer to a rocking chair with music cure therapy. For the intervention group, the intervention will be turned on and for the control, the rocking and music function will not be turned on.

Eligibility criteria: Inclusion Criteria:

* admitted to ICU
* positive delirium evaluation with CAM-ICU or ICDSC

Exclusion Criteria:

* if the patient is evaluated not to be mobilized to a rocking chair
* expressing discomfort and do not wish to be mobilized
* patients with critical illness neuropathy
* patients with levercoma
* patient in ECOM (exstracorporel membrane oxygenation) treatment
* patients that are mentally permanently incompetent
* patients not receiving active life support if needed
* patients that weight more than 130 kg
* patients were informed consent cannot be obtained
* patients admitted because of suicide attempt
* patients with delirium tremens

Primary outcomes:
measure: number of days alive without coma and delirium in the ICU
timeFrame: 14 day follow up
Secondary outcomes:
measure: Number of days admitted to the ICU
timeFrame: 14 day follow up
measure: Delta RASS
timeFrame: 14 day follow up
measure: all cause mortality
timeFrame: 90 day follow up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Department of Intensive care, Copenhagen University Hospital, Denmark
name: Ingrid Egerod, Professor
role: STUDY_CHAIR
References: