Active not recruitingNAINTERVENTIONAL

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

This research is investigating if a special approach, combining relaxation with guided imagination and a gentle massage, can help patients who are seriously ill in intensive care units. These patients often experience confusion, known as delirium. The study aims to see if this combined treatment can reduce confusion and improve patients' overall comfort, sleep, and anxiety levels. It's a pilot study, meaning it's a smaller, initial test to figure out if this treatment is practical to use and if it shows promising results before planning a larger trial. Patients would receive this treatment once a day for up to five days while in intensive care, alongside their usual medical care. The study will also track any unforeseen effects.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

01 Mar 2019

Estimated completion

31 May 2027

Delirium

What is this study about?

When people are very unwell and in intensive care, they can sometimes become confused, a condition called delirium. This confusion can be very distressing and can make it harder for them to recover. Doctors and nurses are always looking for new ways to support these patients and help them feel better, especially by reducing this confusion and improving their comfort.

This study is testing a gentle, combined approach that focuses on relaxation. It involves two main parts: first, a session using guided imagination and relaxation techniques listened to through headphones, and second, a brief, gentle massage. The idea is that these calming activities might help patients in intensive care feel less confused, reduce anxiety, improve their sleep, and lessen any pain they might be feeling. The study will explore if this approach is effective and easy to use in a busy hospital setting.

This is a 'pilot' study, which means it's a smaller, initial investigation. The main goal isn't just to see if the treatment works, but also to understand how practical it is to deliver in hospitals, how many patients are willing to take part, and if the study design itself makes sense. If this pilot study shows promising results and is practical, it could pave the way for bigger studies in the future that might lead to new ways of caring for critically ill patients.

Key takeaways

This study explores a gentle relaxation and massage treatment for critically ill patients.
It aims to reduce confusion (delirium) and improve comfort, sleep, and anxiety.
Participation involves daily 55-minute sessions for up to five days.
There are minimal known risks, and potential benefits include feeling more relaxed.
It's a pilot study to see if the treatment is practical and shows promise.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you would need to be currently in an intensive care unit (ICU) and be at least 18 years old. The medical team would also check whether you have any signs of delirium, using a special checklist. You could still be involved if you are taking part in other medical studies, as long as those studies don't involve sedatives (medicines to make you drowsy or calm) or antipsychotic medicines.

However, there are certain situations where you wouldn't be able to join. For example, if it's expected that you'll only be in the ICU for a very short time (less than three days), or if you have certain brain conditions, ongoing severe sedation, or are in a coma. People with severe mental health issues, dementia, or significant hearing problems that would stop them from using headphones would also not be able to take part. Additionally, if you are on specific medications that relax your muscles (neuromuscular blockers), going through alcohol or substance withdrawal, or taking part in other studies involving sedatives or antipsychotics, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you currently in an Intensive Care Unit (ICU)?
Are you 18 years old or older?
Do you have any signs of confusion (delirium) as assessed by the medical team?
Do you have good enough hearing to use headphones?
Are you able to focus and follow instructions for relaxation?
Are you *not* expected to leave the ICU in the next 3 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two groups. One group would receive the special relaxation and massage treatment, while the other group would continue with standard care and a 'dummy' or placebo treatment (designed to look like the real intervention but without the active components) to ensure fair comparison.

For those in the treatment group, a specially trained nurse, who is not part of your usual care team, would visit you once a day, usually between 10 AM and 11 AM. The session would last about 55 minutes, starting with 40 minutes of relaxation and guided imagination through headphones, followed by a 15-minute gentle massage to your neck, arms, feet, and face. This treatment would be given for up to five days in a row, or until you leave the intensive care unit. During your participation, the study team would collect information about your health and how you're feeling to see if the treatment is having an effect.

Potential risks and benefits

The potential benefits of taking part in this study include the opportunity to receive a relaxation session and massage that has previously been shown to help with pain, anxiety, and sleep in similar situations. While there are no guarantees, you might feel more comfortable or less confused. The risks of participating are considered very small. Similar relaxation techniques have been used before with no reported problems or side effects. However, as with any study, researchers will carefully monitor all participants for any unexpected events, even if they don't seem connected to the treatment. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Misreicordia Hospital
Verified postcode
Edmonton, Canada

Common questions

What is 'delirium'?

Delirium is a state of severe confusion that can happen when someone is very ill, often in intensive care. It can make it hard to think clearly and pay attention.

How long will the treatment sessions last?

Each treatment session, including both the guided relaxation and massage, would last about 55 minutes.

Will I be given new medicines in this study?

No, this study does not involve giving new medicines. It focuses on relaxation and massage techniques.

Who will give the massage?

A specially trained nurse, who is not involved in your regular daily care, will administer the massage.

Can I stop participating if I want to?

Yes, you are free to leave the study at any point, and your usual medical care will not be affected.