Does rocking motion calm delirious patients in ICU? A multicentre randomised clinical trial protocol (RockingICU)
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Does rocking motion calm delirious patients in ICU? A multicentre randomised clinical trial protocol (RockingICU). / Collet, Marie Oxenbøll; Nielsen, Gitte Meldgaard; Bang, Benita; Lærkner, Eva; Fischer, Susanne; Langvad, Anne; Thorn, Linette; Lange, Theis; Egerod, Ingrid.
I: Acta Anaesthesiologica Scandinavica, Bind 65, Nr. 7, 2021, s. 995-1001.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Does rocking motion calm delirious patients in ICU? A multicentre randomised clinical trial protocol (RockingICU)
AU - Collet, Marie Oxenbøll
AU - Nielsen, Gitte Meldgaard
AU - Bang, Benita
AU - Lærkner, Eva
AU - Fischer, Susanne
AU - Langvad, Anne
AU - Thorn, Linette
AU - Lange, Theis
AU - Egerod, Ingrid
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - delirium
KW - intensive care
KW - mobilisation
U2 - 10.1111/aas.13821
DO - 10.1111/aas.13821
M3 - Journal article
C2 - 33735463
AN - SCOPUS:85103185149
VL - 65
SP - 995
EP - 1001
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 7
ER -
ID: 259622564