Bilateral Infant Stimulation Study

Not Applicable

Recruiting

• Conditions: Preterm Birth; Stress Reaction; Parent-Child Relations; Hospitalism in Children
• Interventions: Behavioral: Bilateral alternating stimulation

• Registration Number: NCT06353243
• Lead Sponsor: Oregon Health and Science University

Brief Summary

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

Detailed Description

Objectives:

1. Examine the effect of a bilateral alternating stimulation (BAS) NICU intervention on parental anxiety and psychological distress in the NICU using biological and self-report measurements.

2. Examine the effect of a bilateral alternating stimulation NICU intervention on infants' physiological stress response after parental engagement in the BAS intervention with the infant.

This is a pilot study of bilateral alternating stimulation (BAS) examining the effectiveness as a therapeutic intervention for parental and infant stress in the NICU. It is a single arm design. Participants include parents and their infant that is currently admitted to the NICU. All participants will engage in parent-neonate intervention session, following this, infants will complete a delayed comparison arm (control session) with the interventionist. Infants currently admitted to NICU will be screened for eligibility, and if eligible, the families will be approached for enrollment. Families that enroll will be scheduled for one study session. During study session, parents will wear a heart rate monitor, complete psychologic scales of anxiety, stress, and feelings of closeness to thier infant, parents will be trained on the intervention and then engage in the intervention with their infant. Continuous vital signs will be collected for infant throughout the study session. After the intervention, parents will complete psychologic scales and satisfaction scales. Infants will then be scheduled for follow-up session where an interventionist will engage infant in intervention and vital signs will be collected throughout.

Study Timeline

• Study Start: 2024-02-26
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• admitted to the NICU at the time of study
• greater than 34 weeks gestational age and less than 43 weeks gestational age
• within 4 weeks of admission to NICU at time of initial contact
• have parent or legal guardian willing and able to participate in the study

Exclusion Criteria

• those who are less than 3 days postop from surgical procedures
• current use of psychotropic medications or medications that affect the central nervous system (CNS)
• CNS anomaly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral alternating Stimulation	Bilateral alternating stimulation	positive touch intervention provided by parent to infant using alternating stimulation

Primary Outcome Measures

Name	Time	Method
Parental distress	Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention	Distress Thermometer
Physiologic stress response	total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention	heart rate variability variable- the root mean square of successive differences (RMSSD) which reflects vagal tone
Parental anxiety	Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention	Visual Analog Scale- Anxiety (VAS-A). The VAS scale asks participants to rate current anxiety on a horizontal line ranging from "calm" and "anxious" with scores between 0-100, with higher scores indicating higher levels of anxiety.

Trial Locations

Locations (1)

Oregon Health and Science University Neonatal Intensive Care Unit; 🇺🇸 Portland, Oregon, United States