NCT01433588

The Calmer Project

Calmer: A Novel Approach for Treating Infant Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Children's & Women's Health Centre of British Columbia · Academic / Other
• Sex: All
• Age: 27 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit. Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.

Detailed description

60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DEVICE	The Calmer	This platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin.
OTHER	Standard of Care	Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2011-09-14
• Last updated: 2018-07-17

Locations

1 site across 1 country: Canada