Pilot Study of Nursing Touch and Biobehavioral Stress

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-05-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prematurity Stress Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized cross-over design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The statistician performing the data analysis will be blinded to group.

Study Groups

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Nurse-Administered Touch Intervention

Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.

Group Type EXPERIMENTAL

Nurse-Administered Touch Intervention

Intervention Type 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.

Standard Care

Preterm infants will receive one episode of essential nursing care delivered as standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nurse-Administered Touch Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No