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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04401514
Other study ID # RockingICU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date November 13, 2022

Study information

Verified date March 2024
Source Scandinavian Critical Care Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date November 13, 2022
Est. primary completion date November 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rocking chair therapy
20 min long rocking therapy with music cure. The therapy can be extended if needed

Locations

Country Name City State
Denmark Copenhagen University Hospital, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Scandinavian Critical Care Trials Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of days alive without coma and delirium in the ICU 14 day follow up
Secondary Number of days admitted to the ICU 14 day follow up
Secondary Delta RASS RASS score goes from +4 very agitated to -5 is coma. A score of 0 is equal to alert and calm 14 day follow up
Secondary all cause mortality all cause mortality at additional follow-up 90 day follow up
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