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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral alternating Stimulation | Experimental | positive touch intervention provided by parent to infant using alternating stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral alternating stimulation | Behavioral | positive touch intervention provided by parent to infant using alternating stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Garavatti | Contact | 5034942634 | garavatt@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University Neonatal Intensive Care Unit | Recruiting | Portland | Oregon | 97219 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |