An interventional study of Bilateral alternating stimulation in Parent-Child Relations, Preterm Birth and Stress Reaction, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Supportive care
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.
Objectives:
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 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
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
Distress Thermometer
Time frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
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Oregon Health and Science University