The impact of the PICU diary on post-intensive care syndrome in children and their parents: A pilot randomized controlled trial

Abstract

Objectives: 1) to evaluate the feasibility of a pilot trial on the effectiveness of a pediatric intensive care unit (PICU) diary intervention; 2) to explore group differences in parent's and child's psychological outcomes and children's behaviors after discharge from PICU.

Methods: A non-blinded, single-centered, pilot randomized controlled trial (RCT) was performed in two PICUs at a tertiary care children's hospital in Italy. Children admitted to the PICU, <18 years old, sedated and intubated for ≥ 48 h were eligible. The exclusion criteria included severe disability (Pediatric Overall Performance Category > 3), low Italian communication proficiency, and no life expectancy. The intervention was the PICU narrative diary.

Results: A total of 119 patients were prospectively enrolled from June 2021 to June 2024, of which 60 received a PICU diary, and 59 did not. The composite feasibility outcomes, including eligibility, recruitment, retention, attrition, and protocol adherence met 6 of the 8 criteria. At 1 and 3 months after PICU discharge Post Traumatic Stress Disease (PTSD), anxiety, depression in parents and children, and children's behaviors were measured with validated scales. At the one-month follow-up, parents in the control group had a higher PTSD (21 % vs 11 % p = 0.1) and depression (28 % vs 25 % p = 0.7) and lower anxiety (54 % vs 60 % p = 0.5) compared to the intervention group. At 3 months, lower levels were observed across all outcomes. Parent satisfaction with the intervention was high. The small sample size and lack of blinding were the main study limitations.

Conclusions: The trial was feasible and acceptable. No significant differences in parents' and children' psychological outcomes were found among the study groups.

Implications for clinical practice: PICU diaries could be a valuable support tool for parents and children admitted to PICU. Further evidence through larger RCTs is needed to understand the effect of post-PICU discharge psychological outcomes on children and their parents.

Keywords: Diary; Family Centered Care; Journal; Narrative Medicine; Parent; Pediatric Intensive Care Units; Post Intensive Care Syndrome-family; Post Intensive Care Syndrome-pediatrics; Post intensive Care Syndrome; Randomized Controlled Trial.