Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
NCT Number: NCT05030233
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
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All sexes
Interventional
Not applicable
Columbus, Ohio, 43205, United States
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
Time frame: during intervention or control period, approximately 20 minutes
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Time frame: recovery, 30 minutes after intervention delivery or control period
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Time frame: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes
Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Time frame: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care
Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Time frame: during caregiving episode, approximately 20 minutes
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving.
Time frame: recovery, 30 minutes after intervention delivery or control period
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period.
Ohio State University
Other
Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
Acronym: P-NAT-BIO
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.
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