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A soothing voice in the ICU: could positive suggestions curb Post-Intensive care anxiety?

NCT ID NCT04045210

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether daily psychological support based on positive suggestions, delivered by trained ICU doulas, can reduce anxiety and depression in critically ill adults. Participants are patients on breathing support who are expected to stay in the ICU for more than 48 hours. Half receive the supportive intervention alongside standard care, while the other half receives standard care alone. The study measures mental health outcomes shortly after ICU discharge and again at six months.

What this could mean

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

Active substance
Psychological support based on positive suggestions delivered by ICU doulas
What this could lead to
If effective, this approach could offer a simple, drug-free way to reduce anxiety and depression in critically ill patients during and after an ICU stay.
What could go wrong
The trial is relatively small and the intervention is subjective, so results may vary. It also depends on the skill of the doulas and may not work for everyone.

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

274 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2025

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 to 99 years

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: \- Critically ill adult patients (age \>18) requiring non-invasive ventilation, high flow O2 or mechanical ventilation and expected to stay \>48 hours. Exclusion Criteria: * history of dementia * intellectual disability * suicide attempt * psychotic disorders such as schizophrenia * acute alcohol/substance intoxication or withdrawal * severe metabolic encephalopathy * patients on comfort care * Patients not expected to survive the hospital stay * Non-English speaking.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

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

Critical illness

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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