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Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes

INTRODUCTION: Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium preven...

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Autores principales: Papathanassoglou, Elizabeth D E, Skrobik, Yoanna, Hegadoren, Kathleen, Thompson, Patrica, Stelfox, Henry Thomas, Norris, Colleen, Rose, Louise, Bagshaw, Sean M, Meier, Michael, LoCicero, Cheryl, Ashmore, Rhonda, Sparrow Brulotte, Tiffany, Hassan, Imran, Park, Tanya, Kutsogiannis, Demetrios J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340454/
https://www.ncbi.nlm.nih.gov/pubmed/30782719
http://dx.doi.org/10.1136/bmjopen-2018-023961
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author Papathanassoglou, Elizabeth D E
Skrobik, Yoanna
Hegadoren, Kathleen
Thompson, Patrica
Stelfox, Henry Thomas
Norris, Colleen
Rose, Louise
Bagshaw, Sean M
Meier, Michael
LoCicero, Cheryl
Ashmore, Rhonda
Sparrow Brulotte, Tiffany
Hassan, Imran
Park, Tanya
Kutsogiannis, Demetrios J
author_facet Papathanassoglou, Elizabeth D E
Skrobik, Yoanna
Hegadoren, Kathleen
Thompson, Patrica
Stelfox, Henry Thomas
Norris, Colleen
Rose, Louise
Bagshaw, Sean M
Meier, Michael
LoCicero, Cheryl
Ashmore, Rhonda
Sparrow Brulotte, Tiffany
Hassan, Imran
Park, Tanya
Kutsogiannis, Demetrios J
author_sort Papathanassoglou, Elizabeth D E
collection PubMed
description INTRODUCTION: Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium prevention as a primary outcome. The objective of this study is to assess feasibility and treatment effect estimates of a multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium and for related outcomes. METHODS AND ANALYSIS: Randomised, controlled, single-blinded trial with two parallel groups (1:1 allocation: intervention and standard care) and stratified randomisation (age (18–64 years and ≥65 years) and presence of trauma) with blocking, involving 104 patients with Intensive Care Delirium Screening Checklist (ICDSC): 0–3 recruited from two academic intensive care units (ICUs). Intervention group participants receive the intervention in addition to standard care for up to five consecutive days (or until transfer/discharge); control group participants receive standard care and a sham intervention. We will assess predefined feasibility outcomes, that is, recruitment rates and protocol adherence. The primary clinical outcome is incidence of delirium (ICDSC ≥4). Secondary outcomes include pain scores, inflammatory biomarkers, heart rate variability, stress and quality of life (6 weeks and 4 months) post-ICU discharge. Feasibility measures will be analysed descriptively, and outcomes will be analysed longitudinally. Estimates of effects will be calculated. ETHICS AND DISSEMINATION: The study has received approval from the Human Research Ethics Board, University of Alberta. Results will inform the design of a future multicentre trial. TRIAL REGISTRATION NUMBER: NCT02905812; Pre-results.
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spelling pubmed-63404542019-02-02 Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes Papathanassoglou, Elizabeth D E Skrobik, Yoanna Hegadoren, Kathleen Thompson, Patrica Stelfox, Henry Thomas Norris, Colleen Rose, Louise Bagshaw, Sean M Meier, Michael LoCicero, Cheryl Ashmore, Rhonda Sparrow Brulotte, Tiffany Hassan, Imran Park, Tanya Kutsogiannis, Demetrios J BMJ Open Intensive Care INTRODUCTION: Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium prevention as a primary outcome. The objective of this study is to assess feasibility and treatment effect estimates of a multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium and for related outcomes. METHODS AND ANALYSIS: Randomised, controlled, single-blinded trial with two parallel groups (1:1 allocation: intervention and standard care) and stratified randomisation (age (18–64 years and ≥65 years) and presence of trauma) with blocking, involving 104 patients with Intensive Care Delirium Screening Checklist (ICDSC): 0–3 recruited from two academic intensive care units (ICUs). Intervention group participants receive the intervention in addition to standard care for up to five consecutive days (or until transfer/discharge); control group participants receive standard care and a sham intervention. We will assess predefined feasibility outcomes, that is, recruitment rates and protocol adherence. The primary clinical outcome is incidence of delirium (ICDSC ≥4). Secondary outcomes include pain scores, inflammatory biomarkers, heart rate variability, stress and quality of life (6 weeks and 4 months) post-ICU discharge. Feasibility measures will be analysed descriptively, and outcomes will be analysed longitudinally. Estimates of effects will be calculated. ETHICS AND DISSEMINATION: The study has received approval from the Human Research Ethics Board, University of Alberta. Results will inform the design of a future multicentre trial. TRIAL REGISTRATION NUMBER: NCT02905812; Pre-results. BMJ Publishing Group 2019-01-15 /pmc/articles/PMC6340454/ /pubmed/30782719 http://dx.doi.org/10.1136/bmjopen-2018-023961 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Intensive Care
Papathanassoglou, Elizabeth D E
Skrobik, Yoanna
Hegadoren, Kathleen
Thompson, Patrica
Stelfox, Henry Thomas
Norris, Colleen
Rose, Louise
Bagshaw, Sean M
Meier, Michael
LoCicero, Cheryl
Ashmore, Rhonda
Sparrow Brulotte, Tiffany
Hassan, Imran
Park, Tanya
Kutsogiannis, Demetrios J
Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title_full Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title_fullStr Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title_full_unstemmed Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title_short Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
title_sort relaxation for critically ill patient outcomes and stress-coping enhancement (repose): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340454/
https://www.ncbi.nlm.nih.gov/pubmed/30782719
http://dx.doi.org/10.1136/bmjopen-2018-023961
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