Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the use of therapeutic cuddling versus standard care in critically ill children admitted to a pediatric intensive care unit. It focuses on managing pain, agitation, and delirium, which are common in these children due to illness and treatments. The study addresses the negative effects of usual pain management drugs and explores cuddling as a potential non-drug method to reduce discomfort and anxiety in critically ill children. Participants are randomly assigned to receive either a structured therapeutic cuddling intervention twice daily or standard care, where cuddling might occur but is not prescribed. The cuddling involves in-bed or out-of-bed holding with specific physical contact. The study is conducted over 6 to 12 months at a single pediatric intensive care unit, with a total of 112 children expected to participate. During the study, researchers monitor how feasible it is to enroll and retain participants and deliver the cuddling intervention. They assess key outcomes such as pain, agitation, sedation, delirium, and exposure to pain medications over up to 14 days or until the child leaves the ICU. They also collect experiences from patients, parents, and healthcare professionals about the cuddling therapy. The primary focus is on feasibility within the first 96 hours from ICU admission to discharge or study period end.

Therapeutic Cuddling in Critically Ill Children