N/A
N=19
Pilot Study of Nursing Touch and Biobehavioral Stress
Prematurity · Stress Reaction
Bottom Line
View on ClinicalTrials.gov: NCT05030233 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Average Heart Rate -- During Intervention — 172.6; 168.6 beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nurse-Administered Touch Intervention (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Heart Rate -- During Intervention |
172.6; 168.6 | — |
| PRIMARY Average Heart Rate -- Recovery |
161.7; 158.6 | — |
| SECONDARY Average High-frequency Heart Rate Variability -- During Caregiving Episode |
3.2; 3.2 | — |
| SECONDARY Average High-frequency Heart Rate Variability -- Recovery |
3.0; 3.0 | — |
| SECONDARY Average Frequency of Skin Conductance Responses -- During Caregiving Episode |
0.14; 0.14 | — |
| SECONDARY Average Frequency of Skin Conductance Responses -- Recovery |
0.06; 0.06 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05030233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.