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 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.