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Does rocking motion calm delirious patients in ICU? A multicentre randomised clinical trial protocol (RockingICU)
Author(s) -
Collet Marie Oxenbøll,
Nielsen Gitte Meldgaard,
Bang Benita,
Lærkner Eva,
Fischer Susanne,
Langvad Anne,
Thorn Linette,
Lange Theis,
Egerod Ingrid
Publication year - 2021
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.13821
Subject(s) - medicine , delirium , intensive care unit , randomized controlled trial , clinical trial , psychological intervention , physical therapy , intervention (counseling) , dementia , emergency medicine , intensive care medicine , disease , psychiatry
Background Rocking chair therapy has been explored in patients with dementia to promote the feeling of relaxation, but not in Intensive Care Unit (ICU) patients with delirium. Aim The aim is to investigate the effect of a chair with or without rocking motion on the duration of delirium and intensity of agitation in critically ill patients admitted to the ICU. Design This is an investigator‐initiated pragmatic, multicentre, parallel‐grouped, centrally randomised, stratified, data analyst‐blinded trial. Method We will include patients for 1:1 web‐based randomisation, stratified by site in patients 18 y or older with a positive delirium score identified by a validated tool. We will exclude patients mainly due to mobilisation restrictions, body weight exceeding 130 kg, inability to provide consent, and presence of multiresistant bacteria or viral droplet infections. The intervention group will receive a minimum of 20 min of rocking therapy daily. The control group will be transferred to the same type of chair but without rocking therapy daily. A power calculation with a risk reduction of 20%, a power of 80% with an alpha cut‐off on 5% and further 20% inclusion gives 76 patients in intervention and control group reaching a total of n = 152 inclusion in the trial. Conclusion The RockingICU trial will provide important new knowledge and raise research questions regarding nonpharmacological interventions to alleviate delirium in ICU patients.