Pilot Study of Nursing Touch and Biobehavioral Stress (P-NAT-BIO)

January 30, 2025 updated by: Marliese Nist, Ohio State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nurse-Administered Touch Intervention
Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.
Behavioral: 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.
No Intervention: Standard Care
Preterm infants will receive one episode of essential nursing care delivered as standard care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
during intervention or control period, approximately 20 minutes
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
recovery, 30 minutes after intervention delivery or control period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
during caregiving episode, approximately 20 minutes
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.
recovery, 30 minutes after intervention delivery or control period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
neurobehavior
Time Frame: 35 weeks post-menstrual age
neurobehavior will be assessed using the Neurobehavioral Assessment of the Preterm Infant when infants reach 35 weeks post-menstrual age
35 weeks post-menstrual age
Anderson Behavioral State Scale
Time Frame: recovery, 30 minutes after intervention delivery or control period
behavioral states (ranging from quiet sleep to crying) will be measured during the recovery period as a further behavioral measure of infant recovery from essential nursing care
recovery, 30 minutes after intervention delivery or control period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nationwide Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marliese D. Nist, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021N0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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