Project Title: Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE 1.0): Pilot clinical trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes

Primary Investigator: Elizabeth Papathanassoglou, University of Alberta

Research Associates: Jim Kutsogiannis, University of Alberta, Faculty of Medicine & Dentistry; Research Director, ICU, Royal Alexandra Hospital, Yoanna Skrobik, Faculty of Medicine, McGill University, Kathy Hegadoren, University of Alberta, Faculty of Nursing, Tom Stelfox, School of Medicine, University of Calgary, Colleen Norris, University of Alberta, Faculty of Nursing, Louise Rose, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Sean Bagshaw, University of Alberta, Faculty of Medicine & Dentistry, General Systems ICU, University of Alberta Hospital, Michael Meiers, University of Alberta, Faculty of Medicine & Dentistry, General Systems ICU, University of Alberta Hospital

Patient and Family Advisors: Advisory group to be formed through the ALBERTA SPOR patients and families network


Funding Body: Canadian Institutes of Health Research

Overview: Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard care group to assess the feasibility and treatment effect of a multimodal integrative intervention for delirium prevention and associated detrimental effects

Study Duration: 1 year

Study Center(s): Multi-center (2 sites)

Aim: Based on positive pilot findings, we aim to further assess feasibility and measures of effect of a multimodal intervention consisting of relaxation with guided imagery (RGI), and moderate pressure massage on physiological and psychological outcomes of critically ill patients.

Rationale: ICU delirium is a very common and morbid complication of critical illness, occurs in 35-55% of patients, and is an adverse prognostic marker for survival. Frightening deliric hallucinations/ ideations and pain are perceived as the most severe stressors by critically ill patients. A prolonged stress response and depressed parasympathetic (PNS) activity have been imputed in the pathogenesis of delirium, as has systemic inflammation; both are linked to increased morbidity and mortality. Although some evidence exists on the positive effects of relaxation-inducing approaches (guided imagery, massage believed to increase PNS activity) in critical care, there is a dearth of well-designed studies.

Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment, randomization, adherence, timing of intervention, workload), b) calculate estimates and variance of treatment effect across outcome measures, c) calculate confidence intervals (CI) of incidence proportions, means and standard deviation (SD) of outcome measures in study groups., d) explore underlying physiological mechanisms of efficacy

Number of Subjects: 60 participants per arm. Total: 120 participants

Diagnosis and Main Inclusion Criteria: Critical illness

Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3.

Exclusion Criteria: Patients: a) with expected ICU LOS< 72 hours, b) with acute neurological illness/ trauma, persistent sedation or coma, c) with current history of severe mental health problems and dementia, as per history and psychiatrist assessment, c) with hearing impairment or conditions not permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol withdrawal, g) enrolled in trials of sedatives, antipsychotics.

Study Product, Dose, Route, Regimen: Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a) relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided imagery script and c) music for 15 min (Mozart piano sonata KV 283, G major (2 3) II Adante). Moderate pressure, low velocity (4 N, 1-5cm/s) massage consists of squeezing movements with wide area of contact will be applied in the following order and then reverse order, for 2-3 min at each site: over trapezius muscles, lateral arms, forearms, feet and then over the temple and forehead area.

Duration of administration: Up to 5 days while participants still in the ICU

Reference therapy: Standard care plus placebo to maintain blinding