Bilateral Infant Stimulation Study

NCT06353243 | Recruiting

• 1 other identifier: STUDY00022901
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

neonates; heart rate variability; bilateral stimulation; positive touch; NICU

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

Bilateral alternating Stimulation

EXPERIMENTAL

positive touch intervention provided by parent to infant using alternating stimulation

Behavioral: Bilateral alternating stimulation

Interventions

Bilateral alternating stimulation BEHAVIORAL

positive touch intervention provided by parent to infant using alternating stimulation

Bilateral alternating Stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University Neonatal Intensive Care Unit

Portland, Oregon, 97219, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Fractures, Stress

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Emily Garavatti

CONTACT

5034942634; garavatt@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: February 26, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (1)