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Completed

NCT Number: NCT05030233

Pilot Study of Nursing Touch and Biobehavioral Stress

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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Key information

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse-Administered Touch Intervention

Behavioral

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.

Primary outcomes

  1. Average Heart Rate -- During Intervention

    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

  2. Average Heart Rate -- Recovery

    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

Secondary outcomes

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

    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.

  2. Average High-frequency Heart Rate Variability -- Recovery

    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.

  3. Average Frequency of Skin Conductance Responses -- During Caregiving Episode

    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.

  4. Average Frequency of Skin Conductance Responses -- Recovery

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants

Acronym: P-NAT-BIO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
Feb 18, 2025

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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