The Calmer Project
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: When positioned on the 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
|Official Title:||The Calmer: Pilot Testing a Robot for Managing Acute Pain in Preterm Infants in the Neonatal Intensive Care Nursery (NICU).|
- Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: during the assessment period in the study, estimated to occur over less than an hour. ] [ Designated as safety issue: No ]The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
- Secondary Outcome Measures: Heart Rate [ Time Frame: during and after the assessment period in the study, estimated to be an hour ] [ Designated as safety issue: No ]Heart rate will be recorded during the assessment period, one hour, to denote changes.
- Secondary Outcome Measures: Heart Rate Variability [ Time Frame: during and after assessment period in the study, estimated to be an hour ] [ Designated as safety issue: No ]Heart rate variability during the assessment period will be recorded, monitored and reviewed for changes, estimated to occur over the course of an hour.
|Study Start Date:||October 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Calmer
This therapeutic platform, called the Calmer, moves up and down gently to simulate a breathing motion. It also can play a heart beat sound and is covered with a soft surface which is like skin. It is being tested to see if it mimics Kangaroo care, maternal skin to skin, to help promote better health outcomes. Infants would be placed on it prior, during and after bloodwork to see if it elicits a favorable response.
Device: The Calmer
This platform, called the Calmer, moves up and down gently to simulate a breathing motion. It also can play a heart beat sound and is covered with a soft surface which is like skin. Infants can be placed on it for cares to mimic Kangaroo Care, maternal skin to skin.
Placebo Comparator: Standard Care
Standard of care during bloodwork is receiving a soother and faciliated tucking.
Other: Standard of Care
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
30 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
|Canada, British Columbia|
|BC Children's and Women's Health Centre|
|Vancouver, British Columbia, Canada, V6H3V4|
|Principal Investigator:||Liisa Holsti, PhD||Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC|