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Relaxation Techniques + Massage for Delirium in Critically Ill Patients (REPOSE Trial)

N/A
Recruiting
Led By Elisavet Papathanasoglou, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients hospitalized in one of the study Intensive Care Units (ICUs)
Age over 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

REPOSE Trial Summary

This trial is testing a relaxation intervention to see if it can help prevent delirium in critically ill patients. It is a pilot study, so the main aim is to see if the study is feasible, and to get estimates of the intervention's effect.

Who is the study for?
This trial is for adults over 18 in the ICU with mild to no delirium. They can't be expected to leave the ICU within 72 hours, have acute brain issues or deep sedation, severe mental health problems including dementia, hearing issues preventing headphone use, muscle blocker drugs, substance withdrawal symptoms, or be in other trials for sedatives.Check my eligibility
What is being tested?
The study tests a multimodal intervention called REPOSE (relaxation and guided imagery via headphones for 40 minutes plus a brief moderate pressure massage) against standard care. It aims to see if this approach helps prevent delirium and improves outcomes in critically ill patients.See study design
What are the potential side effects?
Since the interventions are non-invasive relaxation techniques like guided imagery and massage therapy, side effects might include discomfort during the process or potential dissatisfaction with treatment if it doesn’t meet patient expectations.

REPOSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently hospitalized in an ICU participating in the study.
Select...
I am over 18 years old.

REPOSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility 1: Recruitment rate (percentage of patients recruited among eligible patients)
Secondary outcome measures
Cost [Total personnel cost ($) per participant]
Daily analgesic dose
Daily anti-psychotic agent dose (ml/24h)
+17 more
Other outcome measures
90-day survival
APACHE II score
Acetylcholine serum levels
+20 more

REPOSE Trial Design

2Treatment groups
Active Control
Group I: RGI & MassageActive Control1 Intervention
relaxation and guided imagery with background music (RGI) (40 min, headphones) a brief moderate pressure massage session (massage: 15 min)
Group II: ControlActive Control1 Intervention
Sham intervention: Silent headphones to mask the audio component, and presence of an intervention nurse at the bedside with drawn curtains.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
897 Previous Clinical Trials
387,043 Total Patients Enrolled
Royal Alexandra HospitalOTHER
17 Previous Clinical Trials
7,808 Total Patients Enrolled
Elisavet Papathanasoglou, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

RGI & Massage Clinical Trial Eligibility Overview. Trial Name: NCT02905812 — N/A
Delirium Research Study Groups: RGI & Massage, Control
Delirium Clinical Trial 2023: RGI & Massage Highlights & Side Effects. Trial Name: NCT02905812 — N/A
RGI & Massage 2023 Treatment Timeline for Medical Study. Trial Name: NCT02905812 — N/A
~19 spots leftby Jun 2025
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