Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit (RocingICU)
Primary Purpose
Delirium
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rocking chair therapy
Sponsored by
About this trial
This is an interventional treatment trial for Delirium
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
Sites / Locations
- Copenhagen University Hospital, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experiemntal intervention
Control intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
number of days alive without coma and delirium in the ICU
Secondary Outcome Measures
Number of days admitted to the ICU
Delta RASS
RASS score goes from +4 very agitated to -5 is coma. A score of 0 is equal to alert and calm
Full Information
NCT ID
NCT04401514
First Posted
November 4, 2019
Last Updated
November 12, 2020
Sponsor
Scandinavian Critical Care Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT04401514
Brief Title
Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit
Acronym
RocingICU
Official Title
Does ROCKING Chairs Calm Delirious Patients in the Intensive Care Unit: a Multicenter Clinical Randomized Trial (RockingICU)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scandinavian Critical Care Trials Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiemntal intervention
Arm Type
Experimental
Arm Description
The experimental intervention is a 20 min. long rocking chair with music therapy.
Arm Title
Control intervention
Arm Type
Active Comparator
Arm Description
Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on.
Intervention Type
Device
Intervention Name(s)
Rocking chair therapy
Intervention Description
20 min long rocking therapy with music cure. The therapy can be extended if needed
Primary Outcome Measure Information:
Title
number of days alive without coma and delirium in the ICU
Time Frame
14 day follow up
Secondary Outcome Measure Information:
Title
Number of days admitted to the ICU
Time Frame
14 day follow up
Title
Delta RASS
Description
RASS score goes from +4 very agitated to -5 is coma. A score of 0 is equal to alert and calm
Time Frame
14 day follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie O Collet, Nurse
Phone
+44535456949
Email
marie.oxenboell-collet@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte M Nielsen, Nurse
Phone
35454131
Email
gitte.meldgaard.nielsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Egerod, Professor
Organizational Affiliation
Department of Intensive care, Copenhagen University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Perner, MD PhD
Phone
+4535458333
Email
anders.perner@regionh.dk
First Name & Middle Initial & Last Name & Degree
Peter B Hjortrup, MD
Phone
+4535458456
Email
peter.buhl.hjortrup@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anders Perner, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit
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