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Massage and music may keep ICU patients Clear-Headed

NCT ID NCT02905812

Symptom relief Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a daily 15-minute massage plus guided relaxation with music can prevent delirium in critically ill patients. About 120 adults in the ICU will be randomly assigned to receive the relaxation intervention or standard care for up to five days. The main goal is to see if such a study is feasible, with early looks at whether it reduces delirium and stress.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
relaxation with guided imagery and moderate pressure massage
What this could lead to
If it works, this could point toward a simple, drug-free way to reduce delirium in critically ill patients.
What could go wrong
This is a very small pilot study with only 27 participants enrolled so far. It is designed mainly to test feasibility, not to prove effectiveness. Results may not apply to all ICU patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Mar 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

delirium prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delirium

Contacts and locations

Locations

  • Misreicordia Hospital

    Edmonton, Alberta, T5R 4H5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.