Recruiting

Infant Stimulation

Sponsor:

Oregon Health and Science University

Code:

NCT06353243

Conditions

Parent-Child Relations

Preterm Birth

Stress Reaction

Hospitalism in Children

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Bilateral alternating stimulation

Study Details

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

Study ID

NCT06353243

Start date

Feb 26, 2024

Status verified date

May, 2024

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Bilateral alternating Stimulation

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

Primary outcome measure

  • Parental anxiety [ Time Frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention ]
  • Physiologic stress response [ Time Frame: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention ]
  • Parental distress [ Time Frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention ]

Central Contacts and Locations

Central contacts

Emily Garavatti

5034942634garavatt@ohsu.edu

Locations

Oregon Health and Science University Neonatal Intensive Care Unit

Recruiting

Portland, Oregon, United States, 97219

Contacts

Emily Garavatti, MD

503-494-2634garavatt@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

May 3, 2024

Last verified

May, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-05-03.