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

NCT02905812 | Active Not Recruiting DMC

• 1 other identifier: Pro00065430
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Feasibility 1: Recruitment rate (percentage of patients recruited among eligible patients)

  recruitment rate (percentage of patients recruited among eligible patients)

  up to 2 years

Secondary Outcomes (20)

• Eligibility (percentage (%) of eligible patients among patients screened)

  up to 2 years

• Enrollment [Time (min) from admission to enrollment]

  up to 2 years

• Reasons for delayed enrollment (content analysis categories & descriptive statistics of free-text entries describing reasons for delay)

  up to 2 years

• Non-Consent (Percentage of eligible patients declining consent)

  up to 2 years

• Protocol completion (Percentage of participants completing the entire study protocol)

  Up to 25 months

Other Outcomes (23)

• NRS Pain intensity [self-reported (S-R) Numeric Rating Scale (NRS)]

  Up to 30 days (Pre- & post- intervention during first 5 days)

• Pain ratings [Critical Care Pain Observation Tool (CPOT)]

  Up to 30 days (Pre- & post- intervention during first 5 days)

• Pain distress (self-reported (S-R) numeric rating scale (NRS)

  Up to 30 days (Pre- & post- intervention during first 5 days)

Study Arms (2)

RGI & Massage

ACTIVE COMPARATOR

1. relaxation and guided imagery with background music (RGI) (40 min, headphones) 2. a brief moderate pressure massage session (massage: 15 min)

Other: RGI & Massage

Control

NO INTERVENTION

Sham intervention: Silent headphones to mask the audio component, and presence of an intervention nurse at the bedside with drawn curtains.

Interventions

RGI & Massage OTHER

A trained intervention nurse will administer a 15 min moderate pressure massage as well as guided imagery with music once daily for up to five consecutive days.

RGI & Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Royal Alexandra Hospital: collaborator

Study Sites (1)

Misreicordia Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

Related Publications (1)

• Papathanassoglou EDE, Skrobik Y, Hegadoren K, Thompson P, Stelfox HT, Norris C, Rose L, Bagshaw SM, Meier M, LoCicero C, Ashmore R, Sparrow Brulotte T, Hassan I, Park T, Kutsogiannis DJ. Relaxation for Critically ill Patient Outcomes and Stress-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. 2019 Jan 15;9(1):e023961. doi: 10.1136/bmjopen-2018-023961.

  PMID: 30782719 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Massage

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Elisavet Papathanasoglou, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 19, 2016
• Study Start: March 1, 2019
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CA (1)