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

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.

Keywords: autonomic nervous system; complex intervention; critical illness; delirium; guided imagery; music therapy; relaxation.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1

Evidence-based framework for the physiological mechanism implicated in relaxation-induced effects in critical illness. Relaxation acts early at the pathophysiological cascade through which an exaggerated stress response results in proinflammatory effects, suppressed PNS outflow and subsequently in systemic inflammation, multiple organ dysfunction and death. The relaxation response counterbalances the exaggerated stress response and activates PNS and cholinergic anti-inflammatory signalling, which downregulates proinflammatory (eg, HMGB-1) and upregulates anti-inflammatory cytokines, therefore attenuating systemic inflammation and its detrimental organ effects. α7-nAChR, alpha7-nicotinic acetylcholine receptor; HMGB-1, high mobility group box 1; ICU, intensive care unit; PNS, parasympathetic nervous system.

Figure 2

Schematic of study design. Ach, acetylcholine; APACHE, Acute Physiology & Chronic Health Evaluation; C-POT, Critical Care Pain Observation Tool; CRP, C reactive protein; EQ-5D, EuroQol Five Dimensions Questionnaire; HADS, Hospital Anxiety and Depression Scale; HF, high frequency; HMGB, high mobility group box; HRV, heart rate variability; ICDSC, Intensive Care Delirium Screening Checklist; ICU, intensive care unit; IQCODE, Informant Questionnaire on Cognitive Decline in the Elderly; IV, intravenous; LF, low frequency; LOS, length of stay; NRS, numeric rating scale; RASS, Richmond Agitation Sedation Scale; SOFA, sequential organ failure; STAI, State Trait Anxiety Inventory.