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Family voice recordings tested as delirium therapy in ICU

NCT ID NCT07218484

Symptom relief Sponsor: The Methodist Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether playing recorded messages from family and friends—called VoiceLove therapy—can help manage delirium in surgical ICU patients. Fifteen participants will listen to reorientation and calming messages for 25 minutes, twice a day, for three days. The main goal is to see if this approach is feasible and acceptable, not yet to prove it works.

What this could mean

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

Active substance
VoiceLove digital therapy (recorded messages from family and friends)
What this could lead to
If successful, this could point toward a simple, non-drug way to reduce confusion and distress in ICU patients.
What could go wrong
This is a very small pilot study (15 people) with no control group, so results may not be generalizable. It only tests feasibility, not effectiveness.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2026

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: 1. Men and women aged ≥18 years admitted to the hospital after major surgery (elective or non-elective) require a hospital stay of at least five days following surgery, including an ICU stay for at least three days after the surgical procedure 2. At risk of delirium, as per ICU delirium risk score or existing diagnosis 3. Family members or caregivers involved in patient care at least 18 years of age. 4. Clinical team members caring for the patients Exclusion Criteria: * Patients in the ICU who have 1. a history of severe mental illness, 2. admission for a drug overdose, 3. severe vertigo, 4. a history of severe postoperative nausea and vomiting, 5. hearing or visual impairments, 6. preexisting severe dementia (Montreal Cognitive Assessment Score \<15), 7. neurological surgeries.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Confusion delirium

As listed by the trial registrant

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

Delirium

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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