Bilateral Infant Stimulation Study (BLISS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Parent-Child Relations; Stress Reaction; Hospitalism in Children
• Intervention / Treatment: Behavioral: Bilateral alternating stimulation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Garavatti; Phone Number: 5034942634; Email: garavatt@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97219
      • Recruiting
      • Oregon Health and Science University Neonatal Intensive Care Unit
      • Contact: Emily Garavatti, MD; Phone Number: 503-494-2634; Email: garavatt@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral alternating Stimulation; positive touch intervention provided by parent to infant using alternating stimulation	Behavioral: Bilateral alternating stimulation; positive touch intervention provided by parent to infant using alternating stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic stress response	heart rate variability variable- the root mean square of successive differences (RMSSD) which reflects vagal tone	total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention
Parental distress	Distress Thermometer	Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: neonates; NICU; heart rate variability; bilateral stimulation; positive touch
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Fractures, Stress
• Other Study ID Numbers: STUDY00022901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No