Pilot Study of Nursing Touch and Biobehavioral Stress

Ohio State University19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prematurity Stress Reaction

Interventions

Nurse-Administered Touch InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMax age: 10 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Born prematurely between 27 and 30 weeks post-menstrual age. * Born to mothers who are English-speaking and able to provide informed consent. * No more than 10 days old at the time of enrollment. Exclusion Criteria: * Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function. * Diagnosed with a congenital anomaly requiring surgery during the neonatal period. * Receiving scheduled steroids or vasopressors. * Skin conditions that preclude the attachment of sensors. * Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy. * Diagnosed with chromosomal abnormalities. * Requiring special isolation with universal gloving for potentially infectious pathogens.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Average Heart Rate -- During Intervention

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 intervention or control period, approximately 20 minutes

Average Heart Rate -- Recovery

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

Secondary Outcomes

Average High-frequency Heart Rate Variability -- During Caregiving Episode

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: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes

Average High-frequency Heart Rate Variability -- Recovery

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: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care

Average Frequency of Skin Conductance Responses -- During Caregiving Episode

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.

Data from ClinicalTrials.gov

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