Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit (RocingICU)

Does ROCKING Chairs Calm Delirious Patients in the Intensive Care Unit: a Multicenter Clinical Randomized Trial (RockingICU)

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Device: Rocking chair therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie O Collet, Nurse; Phone Number: +44535456949; Email: marie.oxenboell-collet@regionh.dk
• Study Contact Backup: Name: Gitte M Nielsen, Nurse; Phone Number: 35454131; Email: gitte.meldgaard.nielsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 108 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiemntal intervention; The experimental intervention is a 20 min. long rocking chair with music therapy.	Device: Rocking chair therapy; 20 min long rocking therapy with music cure. The therapy can be extended if needed
Active Comparator: Control intervention; Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on.	Device: Rocking chair therapy; 20 min long rocking therapy with music cure. The therapy can be extended if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of days alive without coma and delirium in the ICU	14 day follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days admitted to the ICU		14 day follow up
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
all cause mortality	all cause mortality at additional follow-up	90 day follow up

Collaborators and Investigators

• Sponsor: Scandinavian Critical Care Trials Group
• Investigators: Study Chair: Ingrid Egerod, Professor, Department of Intensive care, Copenhagen University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 13, 2022
• Study Completion (Actual): November 13, 2022

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: RockingICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No