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.

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.

• 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
• Journal: BMJ open (BMJ Open) Vol. 9 Issue 1 Pg. e023961 (01 15 2019) ISSN: 2044-6055 [Electronic] England
• PMID: 30782719 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 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.

Topics

• Adolescent
• Adult
• Critical Illness (psychology, therapy)
• Delirium (psychology, therapy)
• Female
• Humans
• Male
• Middle Aged
• Multicenter Studies as Topic
• Pilot Projects
• Quality of Life
• Randomized Controlled Trials as Topic
• Relaxation Therapy (methods)
• Single-Blind Method
• Treatment Outcome
• Young Adult