IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
NCT Number: NCT00917631
A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3K 6R8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding.
Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary.
Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes).
Time frame: Baseline until completion of heelstick
Time frame: The length of time for heart rate and oxygen saturation to return to normal (baseline).
Time frame: Baseline until completion of heelstick
Time frame: Baseline and 20 minutes post heelstick
Time frame: Baseline to completion of the heelstick
Time frame: Baseline to completion of the heelstick
IWK Health Centre
Other
Acronym: CComforT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07689370
Neurologic Manifestations, Pain
Köseköy, Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT07669948
Neurologic Manifestations, Pain
Mersin, Province, Turkey (Türkiye)
View Trial DetailsNCT07704112
Behavioral Changes, Neurologic Manifestations
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06983093
Fear Needles, Iatrophobia
Konya, Turkey (Türkiye)
View Trial Details