Relaxation for Critically Ill Patient Outcomes and Tress-coping Enhancement (REPOSE): a Protocol for a Pilot Randomised Trial of an Integrative Intervention to Improve Critically Ill Patients' Delirium and Related Outcomes

Overview

Journal BMJ Open

Specialty General Medicine

Date 2019 Feb 21

PMID 30782719

Citations 1

Authors

Elizabeth D E Papathanassoglou

Yoanna Skrobik

Kathleen Hegadoren

Patrica Thompson

Henry Thomas Stelfox

Colleen Norris

Louise Rose

Sean M Bagshaw

Michael Meier

Cheryl LoCicero

Rhonda Ashmore

Tiffany Sparrow Brulotte

Imran Hassan

Tanya Park

Demetrios J Kutsogiannis

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

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PMID: 34586543 PMC: 8918184. DOI: 10.1007/s10072-021-05621-4.

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