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?

This trial tests a new method to prevent delirium (a state of confusion) in critically ill ICU patients. The treatment, called RGI & Massage, combines relaxation techniques with guided imagery (listening to calming stories or music) and gentle massage. The researchers aim to determine if this approach can improve both mental and physical health outcomes. Suitable candidates for this trial are ICU patients without severe mental health problems or hearing issues that would prevent headphone use. Participants will receive either the treatment or standard care with a placebo to ensure fair results. As an unphased trial, this study provides a unique opportunity to explore innovative care methods that could enhance recovery experiences for ICU patients.

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.

What prior data suggests that this methodology is safe for critically ill patients?

Research has shown that relaxation techniques and massage, such as guided imagery and gentle touch, are generally safe. Many places use these methods, and most people tolerate them well. Studies have found that relaxation and guided imagery, combined with massage, can enhance the well-being of very sick patients without causing serious side effects. Overall, these treatments are considered low-risk and safe for improving patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for delirium in critically ill patients rely on medications like antipsychotics, which often come with a host of side effects and variable effectiveness. Researchers are excited about using Relaxation and Guided Imagery (RGI) combined with massage because it offers a non-drug option that enhances patient comfort and potentially improves outcomes without medication risks. This approach uses soothing music and guided visualization to calm the mind, paired with moderate pressure massage to reduce physical tension, making it a holistic alternative that could benefit patients who may not tolerate traditional drug therapies well.

What evidence suggests that this methodology is effective for delirium prevention?

Research has shown that relaxation with guided imagery (RGI) and gentle massage may help prevent delirium in seriously ill patients. In this trial, participants in the RGI & Massage arm will receive a combination of guided relaxation with background music and a brief moderate pressure massage. Earlier studies found this combination promising in reducing stress and improving mental health. Patients who received these treatments exhibited fewer delirium symptoms than those who did not. The blend of guided relaxation, calming music, and light massage soothes the mind and body. This approach aims to support patients' mental well-being while they are in intensive care. ^{1 2 3 5 6}

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

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

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

I am over 18 years old.

Exclusion Criteria

You have trouble hearing or cannot use headphones.

You are currently going through substance or alcohol withdrawal.

I am taking medication for muscle control.

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6340454/

Relaxation for Critically ill Patient Outcomes and Stress ... A multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02905812

Study Details | NCT02905812 | Pilot ... Multimodal integrative interventions demonstrate superior efficacy compared to uni-dimensional ones (32). It includes: a) relaxation and guided imagery (RGI) ( ...

3. withpower.com withpower.com/trial/phase-delirium-2018-14854

Relaxation Techniques + Massage for Delirium in Critically Ill ... The REPOSE medical study, being run by University of Alberta, is evaluating whether RGI & Massage will have tolerable side effects & efficacy for patients ...

4. policylab.us policylab.us/clinical-trials/l/ca/conditions/delirium

Canada based Delirium Clinical Trials & Research Studies Near ... ... intervention consisting of relaxation with guided imagery (RGI), and moderate pressure massage on physiological and psychological outcomes of critically ill ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/9/1/e023961.draft-revisions.pdf

BMJ Open is committed to open peer review. As ... Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): ... guided imagery, and moderate pressure touch-massage ... 30 min recorded ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1036731417301649

The effect of guided imagery on physiological and ... We systematically reviewed evidence on the effects of GI on physiological and psychological outcomes of adult critically ill patients and extracted implications ...