Therapeutic cuddling for critically ill children
Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial
This project will try therapeutic cuddling to reduce pain, agitation, and delirium in children admitted to the pediatric intensive care unit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT07562048 on ClinicalTrials.gov |
What this trial studies
This interventional program compares adding therapeutic cuddling (for example kangaroo care, clothed cuddling, or comfort holding) to standard PICU care versus standard care alone for children expected to remain in the unit more than 48 hours. Participants are enrolled at a single center and receive regular, structured comforting sessions in addition to usual medical management. Key outcomes include measures of pain, ICU delirium and agitation, sedative/analgesic exposure, and length of stay. The approach tests a non-pharmacologic option intended to reduce reliance on opioids and benzodiazepines and their associated harms.
Who should consider this trial
Good fit: Children in the pediatric intensive care unit at Alberta Children's Hospital who are expected to stay more than 48 hours and are clinically stable enough to receive physical comforting are ideal candidates.
Not a fit: Children with very short admissions (<48 hours), those who are too medically unstable or have contraindications to holding, or those previously enrolled are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, therapeutic cuddling could lower pain and delirium, reduce sedative medication use, and shorten ICU stays for children.
How similar studies have performed: Comfort holding and kangaroo care have supportive evidence in newborns and non‑ICU pediatric settings, but high-quality data in critically ill children are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- expected duration of admission of \> 48 hours. Exclusion Criteria: * Previously enrolled
Where this trial is running
Calgary, Alberta
- Alberta Children's Hospital — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Laurie A Lee, PhD
- Email: laurie.lee@ucalgary.ca
- Phone: 403-510-7661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.