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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients hospitalized in one of the study Intensive Care Units (ICUs)

• Age over 18 years

• Intensive Care Delirium Screening Checklist (ICDSC):0-3

• patients enrolled in other investigative trials not involving sedative, psychoactive medications

Locations
Other Locations
Canada
Misreicordia Hospital
RECRUITING
Edmonton
Contact Information
Primary
Elisavet Papathanasoglou, PhD
papathan@ualberta.ca
780-492-5674
Backup
Jim Kutsogiannis Kutsogiannis, MD
djk3@ualberta.ca
780-735-4096
Time Frame
Start Date: 2019-03-01
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 120
Treatments
Active_comparator: RGI & Massage
1. relaxation and guided imagery with background music (RGI) (40 min, headphones)~2. a brief moderate pressure massage session (massage: 15 min)
No_intervention: Control
Sham intervention: Silent headphones to mask the audio component, and presence of an intervention nurse at the bedside with drawn curtains.
Related Therapeutic Areas
Sponsors
Collaborators: Royal Alexandra Hospital
Leads: University of Alberta

This content was sourced from clinicaltrials.gov