Integrative intervention to improve delirium in critically ill patients
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
NA · University of Alberta · NCT02905812
This study is testing a combination of relaxation techniques and massage to see if it can help prevent delirium in critically ill patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT02905812 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to assess the feasibility and treatment effects of a multimodal integrative intervention designed to prevent delirium and its associated detrimental effects in critically ill patients. The intervention includes relaxation with guided imagery and moderate pressure massage, delivered over a 55-minute session. The study will evaluate various outcome measures, including physiological and psychological effects, while also exploring the underlying mechanisms of efficacy. Conducted across two sites, the trial will involve a total of six participants over a duration of two years and two months.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged over 18 years who are hospitalized in the ICU and have a low risk of delirium.
Not a fit: Patients with acute neurological illnesses, severe mental health problems, or those expected to stay in the ICU for less than 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of delirium and improve overall outcomes for critically ill patients.
How similar studies have performed: Previous studies have shown that similar relaxation interventions can effectively decrease pain and anxiety, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * patients with expected Intensive Care Unit length of stay \< 72 hours * patients with acute neurological illness/ trauma, persistent sedation or coma * patients with current history of severe mental health problems and dementia, as per history and psychiatrist assessment * patients with hearing impairment or conditions not permitting use of headphones * patients on neuro-muscular blocker medications * patients with substance/ alcohol withdrawal * patients enrolled in trials of sedatives, antipsychotics
Where this trial is running
Edmonton, Alberta
- Misreicordia Hospital — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Elisavet Papathanasoglou, PhD — University of Alberta
- Study coordinator: Elisavet Papathanasoglou, PhD
- Email: papathan@ualberta.ca
- Phone: 780-492-5674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delirium