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Can a Chaplain's visit calm ICU families? new trial aims to find out

NCT ID NCT07228299

Symptom relief Sponsor: Indiana University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tests whether structured spiritual care from a chaplain can reduce anxiety and improve well-being for family members of ICU patients who cannot make decisions for themselves. The chaplain will meet with the family surrogate several times and stay in touch weekly. The trial will enroll 64 patient-family pairs at multiple hospitals.

What this could mean

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

Active substance
Spiritual Care Assessment and Intervention (SCAI) framework delivered by a chaplain
What this could lead to
If it works, this could provide a simple, non-drug way to ease anxiety and boost spiritual well-being for families making tough decisions in the ICU.
What could go wrong
This is a small early-stage trial with only 64 participants, so results may not apply to all ICU families. The intervention is behavioral, so effects may be modest or hard to measure.

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 64 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 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.

We will enroll patient/surrogate dyads. Patients will be eligible if: * They are age 18 or older at the time of screening. * They are judged to lack decisional capacity based on either: a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands). \* They have an eligible surrogate willing to participate. Surrogates will be eligible if: * They are age 18 or older, * They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law. Patient/surrogate dyads will be ineligible if: \* They are unable to complete enrollment activities within 96 hours of admission to the ICU. Patients will be ineligible if: * They are being discharged from the ICU within 24 hours. * They are intubated for surgery but expected to be extubated soon (typically within 24 hours). * They are imminently dying or have a planned terminal wean. Surrogates will be ineligible if: \*They are unable to complete study procedures in English.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Personal Satisfaction

As listed by the trial registrant

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

Anxiety Satisfaction Well being

How to take part

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

  1. The places running it

    2 sites. 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

  • University of California- San Francisco

    San Francisco, California, 94143, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

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