NCT06117345: PICUJournal

Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal

ENROLLING BY INVITATION NA Last updated 2 June 2025

What this trial tests

NA trial testing PICU Journal in Critical Illness in 75 participants. Enrolling by invitation.

Timeline

15 May 2024

Primary endpoint
15 July 2026

15 November 2026

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	75
Start date	15 May 2024
Primary completion	15 July 2026
Estimated completion	15 November 2026
Sites	1 location across United States

Drugs / interventions tested

• PICU Journal

Conditions studied

• Critical Illness — all drugs for Critical Illness →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU.

Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019).

Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.