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

Journal Publication ResearchOnline@JCU
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.
Tanya Park
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.

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BMJ Open

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9

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2044-6055

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9

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BMJ Group

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DOI

10.1136/bmjopen-2018-023961