Bilateral Infant Stimulation Study

NCT ID: NCT06353243

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2024-08-31

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.

Conditions

Parent-Child Relations; Preterm Birth; Stress Reaction; Hospitalism in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bilateral alternating Stimulation

positive touch intervention provided by parent to infant using alternating stimulation

Group Type: EXPERIMENTAL

Bilateral alternating stimulation

Intervention Type: BEHAVIORAL

positive touch intervention provided by parent to infant using alternating stimulation

Interventions

Bilateral alternating stimulation

positive touch intervention provided by parent to infant using alternating stimulation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Kristen Mackiewicz Seghete

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health and Science University Neonatal Intensive Care Unit

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily Garavatti

Role: CONTACT

garavatt@ohsu.edu

5034942634

Facility Contacts

Emily Garavatti, MD

Role: primary

garavatt@ohsu.edu

503-494-2634

Other Identifiers

STUDY00022901

Identifier Type: -

Identifier Source: org_study_id