Therapeutic cuddling for critically ill children
Official title: Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial
Run by University of Calgary · NCT07562048 · Data updated 2026-11-12
This project will try therapeutic cuddling to reduce pain, agitation, and delirium in children admitted to the pediatric intensive care unit.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | December 8, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07562048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- expected duration of admission of \> 48 hours. Exclusion Criteria: * Previously enrolled
Where it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.