Effect of the Ansileve Supplement on the Well-being of Parents of Children Who Have Experienced a Medical Emergency: A Randomized Controlled Study (ParentSOS)

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.

The main questions are:

1. Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo?
2. Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?

Researchers will compare participants receiving Ansileve SOS spray and/or Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.

Participants will:

• Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
• Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event [Impact of Event Scale - Revised (IES-R)], and anxiety symptoms [Generalized Anxiety Disorder Scale (GAD-7)] at baseline and during follow-up
• Receive either Ansileve SOS spray or placebo spray at study enrolment.
• Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group
• Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.