Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit

NCT04401514 | Completed

• 1 other identifier: RockingICU
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• number of days alive without coma and delirium in the ICU

  14 day follow up

Secondary Outcomes (3)

• Number of days admitted to the ICU

  14 day follow up

• Delta RASS

  14 day follow up

• all cause mortality

  90 day follow up

Study Arms (2)

Experiemntal intervention

EXPERIMENTAL

The experimental intervention is a 20 min. long rocking chair with music therapy.

Device: Rocking chair therapy

Control intervention

ACTIVE COMPARATOR

Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on.

Device: Rocking chair therapy

Interventions

Rocking chair therapy DEVICE

20 min long rocking therapy with music cure. The therapy can be extended if needed

Control intervention; Experiemntal intervention

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scandinavian Critical Care Trials Group: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Collet MO, Nielsen GM, Thorn L, Laerkner E, Fischer S, Bang B, Langvad A, Granholm A, Egerod I. Rocking Motion Therapy for Delirious Patients in the ICU: A Multicenter Randomized Clinical Trial. Crit Care Med. 2025 Jan 1;53(1):e161-e172. doi: 10.1097/CCM.0000000000006495. Epub 2024 Nov 15.

  PMID: 39792532 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ingrid Egerod, Professor

  Department of Intensive care, Copenhagen University Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: May 26, 2020
• Study Start: June 1, 2020
• Primary Completion: November 13, 2022
• Study Completion: November 13, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)