Bilateral Infant Stimulation Study

Preterm Birth Clinical Trial

— BLISS  

Official title:

Pilot of the Bilateral Infant Stimulation Study (BLISS): A Parent Provided Positive-Touch Intervention Targeting Stress in the Neonatal Intensive Care Unity (NICU)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353243
• Other study ID #: STUDY00022901
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: Emily Garavatti
• Phone: 5034942634
• Email: garavatt[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Stress
• Hospitalism in Children
• Parent-Child Relations
• Premature Birth
• Preterm Birth
• Stress Reaction

Intervention

Behavioral:
• Bilateral alternating stimulation
positive touch intervention provided by parent to infant using alternating stimulation

Locations

Country	Name	City	State
United States	Oregon Health and Science University Neonatal Intensive Care Unit	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental anxiety	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.	Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
Primary	Physiologic stress response	heart rate variability variable- the root mean square of successive di?erences (RMSSD) which re?ects vagal tone	total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention
Primary	Parental distress	Distress Thermometer	Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention