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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,014 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the greatest number of participants that have enrolled in this trial?

"Affirmative, the clinicaltrials.gov registry indicates that this medical trial is currently recruiting patients - it was initially posted on March 1st 2019 and most recently modified on July 14th 2022. The investigation requires 120 individuals to be recruited from a single site."

Answered by AI

Is this experiment looking to enlist more participants at the present?

"Affirmative. Clinicaltrials.gov has data confirming that the clinical study, which was initiated on March 1st 2019, is still actively searching for participants. The trial requires 120 patients to be recruited from one medical centre."

Answered by AI

Recent research and studies

sJournal

Relaxation for Critically Ill Patient Outcomes And<i>s</i>tress-coping Enhancement (REPOSE): A Protocol for a Pilot Randomised Trial of an Integrative Intervention to Improve Critically Ill Patients’ Delirium and Related Outcomes

Papathanassoglou, Elizabeth D E, Yoanna Skrobik, Kathleen Hegadoren, Patrica Thompson, Henry Thomas Stelfox, Colleen Norris, Louise Rose, et al.. 2019. “Relaxation for Critically Ill Patient Outcomes Andstress-coping Enhancement (REPOSE): A Protocol for a Pilot Randomised Trial of an Integrative Intervention to Improve Critically Ill Patients’ Delirium and Related Outcomes”. BMJ Open. BMJ. doi:10.1136/bmjopen-2018-023961.

clinicaltrials.govStudy

Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients' Delirium and Related Outcomes

Elisavet Papathanasoglou 2019. "Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients' Delirium and Related Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02905812.