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Writing away the trauma: diaries may ease PTSD in parents of ICU kids

NCT ID NCT04961697

Knowledge-focused Sponsor: D'Or Institute for Research and Education 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether keeping a hospital diary during a child's stay in the pediatric intensive care unit (PICU) could improve mental health outcomes for families. Over 400 families participated across four PICUs in Rio de Janeiro. Researchers measured anxiety, depression, PTSD, and quality of life at discharge and 60 days later. The goal is to see if this simple, low-cost tool can help families process their experience and reduce long-term emotional distress.

What this could mean

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

Active substance
hospital diaries
What this could lead to
If it works, this could point toward a simple, low-cost way to support families after a child's intensive care stay.
What could go wrong
This is an early-stage, observational study with no blinding or placebo, so results may be influenced by other factors. The diaries may not reduce mental health symptoms for all families.

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

431 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2021

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

29 days to 12 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: * Patients between age limits admitted in PICU for clinical or surgical reasons with 36 or more hours of stay and their main family member. * Physicians, registered nurses, nurse technicians, physical therapists and other professionals working in participants PICU involved in caring for patients and their families and taking notes in the diaries Exclusion Criteria: * Patients admitted for monitorization or elective low-complexity surgeries * Patients readmitted between the first admission and the first follow-up visit * Patients in palliative care * Families with linguistic or comprehension barriers * Families residencies situated outside Rio de Janeiro metropolitan region

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder Patient Satisfaction post-traumatic stress disorder postintensive care syndrome

As listed by the trial registrant

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

Anxiety Depression Post intensive care syndrome Quality of life Satisfaction, patient Stress disorders, post-traumatic

Contacts and locations

Locations

  • D'Or Institute for Research and Education

    Rio de Janeiro, Rio de Janeiro, 22281-100, Brazil

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