Relaxation Techniques + Massage for Delirium in Critically Ill Patients

(REPOSE Trial)

Overseen By Elisavet Papathanasoglou, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Sedatives, Antipsychotics

Disqualifiers: Severe mental health, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on neuro-muscular blockers or enrolled in trials involving sedatives or antipsychotics.

Is the combination of relaxation techniques and massage safe for humans?

Relaxation techniques and massage, including guided imagery and moderate pressure touch, are generally considered safe for humans. They have been used in various studies to help with sleep, stress, and psychological distress without significant safety concerns. ^{1 2 3 4 5}

How does the REPOSE intervention treatment differ from other treatments for delirium in critically ill patients?

The REPOSE intervention is unique because it combines relaxation techniques, guided imagery (using mental visualization to promote relaxation), and moderate pressure massage to prevent delirium in critically ill patients, whereas most existing treatments focus on medication or environmental changes. This multimodal approach targets both the mind and body, aiming to reduce stress and improve patient outcomes without relying on drugs. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment RGI & Massage, REPOSE intervention, Relaxation and Guided Imagery (RGI), Moderate Pressure Massage for delirium in critically ill patients?

Research suggests that relaxation and guided imagery can improve sleep in critically ill adults, which may indirectly help with delirium. Additionally, massage has been studied for its potential to affect delirium and sleep, indicating that these components might be beneficial in managing delirium in critically ill patients. ^{1 2 3 5 8}

Who Is on the Research Team?

Elisavet Papathanasoglou, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently hospitalized in an ICU participating in the study.

I am over 18 years old.

You have a low score on the Intensive Care Delirium Screening Checklist (ICDSC).

Exclusion Criteria

You have trouble hearing or cannot use headphones.

I am taking medication for muscle control.

You are currently going through substance or alcohol withdrawal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the REPOSE intervention, which includes relaxation and guided imagery with background music and a brief moderate pressure massage session, administered once daily for up to 5 consecutive days while in the ICU.

5 days

Daily sessions in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up 48-96 hours after ICU discharge and 3 months post-hospital discharge.

3 months

Long-term Follow-up

Participants' quality of life and other outcomes are assessed at 6 months post-hospital discharge.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• RGI & Massage

Trial Overview 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.

How Is the Trial Designed?

Group I: RGI & Massage Active Control 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Royal Alexandra Hospital

Collaborator

Trials

20

Recruited

9,300+

Published Research Related to This Trial

This study is a randomized controlled trial involving 104 patients in intensive care, aiming to assess the feasibility and effectiveness of a multimodal intervention (relaxation, guided imagery, and massage) to prevent delirium, a common complication in critically ill patients.

The primary outcome is the incidence of delirium, with secondary outcomes including pain, inflammation, heart rate variability, stress, and quality of life, which will help determine if this integrative approach can improve patient outcomes in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Papathanassoglou, EDE., Skrobik, Y., Hegadoren, K., et al.[2020]

A study involving 36 critically ill adults showed that a combination of relaxation and imagery significantly improved sleep quality, as measured by a visual analog sleep scale.

Men responded quickly to the intervention, showing immediate improvements in sleep, while women experienced a delayed response, initially showing a drop in sleep quality before improving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of relaxation and imagery on the sleep of critically ill adults. Richardson, S.[2019]

In a study involving 150 patients in a cardiac intensive care unit, neither massage with aromatic oil nor massage without oil showed a significant effect on reducing delirium compared to a control group.

Although the incidence of delirium decreased for all groups from day 1 to day 3, the study concluded that massage, regardless of the use of aroma, did not provide measurable benefits in managing delirium in post-surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial. Askarkafi, F., Rayyani, M., Dehghan, M.[2022]

Guided imagery (GI) has shown promising effects in reducing pain and anxiety, as well as decreasing the length of stay in critically ill patients, based on a systematic review of 10 studies involving 1391 participants.

There were no reported side effects from GI, suggesting it is a safe, patient-centered approach that could improve various outcomes, including sleep quality and patient satisfaction, warranting further research in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of guided imagery on physiological and psychological outcomes of adult ICU patients: A systematic literature review and methodological implications. Hadjibalassi, M., Lambrinou, E., Papastavrou, E., et al.[2019]

A randomized controlled trial involving 34 critically ill patients explored the feasibility of using aromatherapy massage to improve sleep, but only 5 participants in the aromatherapy group completed the outcomes for analysis, indicating challenges in recruitment and data collection.

The study concluded that a larger trial on the effects of aromatherapy massage on sleep in ICU patients is not feasible, emphasizing the importance of assessing the practicality of complex interventions in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An aromatherapy massage intervention on sleep in the ICU: A randomized controlled feasibility study. Pattison, N., O'Gara, G., Thomas, K., et al.[2023]

Relaxation with guided imagery (RGI) did not significantly reduce psychological distress or improve health-seeking behaviors among employees in this study, indicating limited efficacy in this working population.

Despite the lack of significant results, RGI is a simple and inexpensive technique that may still benefit some individuals, suggesting a need for further research to explore its potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation with guided imagery: effects on employees' psychological distress and health seeking behaviors. Vines, SW.[2008]

Delirium in critically ill patients is a complex clinical syndrome that can be influenced by factors such as pain, anxiety, and sleep disruption, highlighting the importance of comprehensive management strategies to address these underlying causes.

Early identification and intervention, including daily assessments and environmental improvements, can significantly reduce the incidence and duration of delirium, ultimately improving patient outcomes in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experts consensus on the management of delirium in critically ill patients]. Tang, B., Wang, XT., Chen, WJ., et al.[2019]

Massage, music therapy, and therapeutic touch are safe and effective interventions that can promote relaxation and potentially improve sleep in critically ill patients, and should be routinely applied by trained ICU nurses.

Environmental interventions, such as reducing noise and minimizing sleep interruptions, are also safe and logical strategies for enhancing sleep in ICU settings, while the safety of aromatherapy and alternative sedatives like melatonin remains uncertain and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of complementary and alternative therapies to promote sleep in critically ill patients. Richards, K., Nagel, C., Markie, M., et al.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of relaxation and imagery on the sleep of critically ill adults. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

The effect of guided imagery on physiological and psychological outcomes of adult ICU patients: A systematic literature review and methodological implications. [2019]

5. England pubmed.ncbi.nlm.nih.gov

An aromatherapy massage intervention on sleep in the ICU: A randomized controlled feasibility study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Relaxation with guided imagery: effects on employees' psychological distress and health seeking behaviors. [2008]

7. China pubmed.ncbi.nlm.nih.gov

[Experts consensus on the management of delirium in critically ill patients]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Use of complementary and alternative therapies to promote sleep in critically ill patients. [2019]