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.
Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To 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.
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.
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 KV283, G major (2 3) II Andante).
Duration of administration: Up to 5 days while participants still in the ICU.
Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology:
Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on
generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals
will be presented with estimated effects. Primary analysis will be based on all available
data utilizing data from all assessments.