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Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU

NCT06252883 · Cook County Health
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Official title
Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.
About this study
The NICU can be a stressful environment for new mothers and fathers irrespective of whether NICU stay was anticipated or not. Parental role alteration remains one of the major parental stressors. Our NICU practices family centered care, with efforts to reduce NICU associated stress by daily updates (via phone and in person/by bedside), encouraging parent-infant skin to skin as infant's clinical state permits, allowing physical touch of baby with hands to stimulate bonding, amongst other practices. Studies have looked at stress as well as psychological distress in relation with parental resilience in the NICU, but none have looked at stress level in NICU parents in relation to their infant's clinical status at the time of assessment while adding an intervention. Our study, to the best of our knowledge, will be the first to evaluate the impact of serial bedside video call w/audio feature to NICU parents, permitting audio interaction with their infant, with an interval assessment of parent's stress level. Parents will be randomized into 2 groups. The parent/guardian designated at the time of initial enrollment/consenting will be asked to complete the forms at subsequent assessments and participate in the study intervention. Data collection will be at 3 points during an 8-week period. Parental assessment will be done when they are visiting their infant. Parents will receive the following questionnaires during the 3 assessments and Infant clinical severity score will be completed at all assessments by the research investigator. Assessment 1 (7-10 days of life): Socio-demographic sheet, MSPSS, PSS-NICU Assessment 2 (14-21 days of life): PSS-NICU Assessment 3 (6-8 weeks of life): MSPSS, PSS-NICU, STAI Y-1, STAI Y-2 Socio-demographic data Infant Clinical severity Score: This quantifies the degree of infant clinical severity at the time of assessment for our study. This score is not intended to portray mortality or morbidity. Multidimensional Scale of Perceived Social support (MSPSS) Parental stressor Scale- Neonatal Intensive Care unit (PSS-NICU) 3 subtype State- Trait-Anxiety-Inventory Form Y-1 - is a well validated form used to measure one's anxiety state at a specific moment in time. State- Trait-Anxiety-Inventory Form Y-2 - is a well validated tool that requires the individual to describe how they generally feel.
Eligibility criteria
Inclusion Criteria: \- Newborns with 7 days or more of NICU stay Exclusion Criteria: Infant with * intrauterine drug exposure * major critical congenital cardiac anomaly * major neurologic anomaly * chromosomal disorder.
Study design
Enrollment target: 70 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2024-06-01
Estimated completion: 2025-05
Last updated: 2024-07-24
Interventions
Other: Serial bedside video call communication
Primary outcomes
  • Change in the stress level of parents of infants admitted to NICU more than 7 days. (8 weeks after infant's enrollment or till infant is discharged, whichever comes first.)
Sponsor
Cook County Health · other_gov
Contacts & investigators
ContactNanda Vishakha, MD · contact · vishakha.nanda@cookcountyhhs.org · 312-864-6000
ContactUgoeze Otome, MD · contact · ugoeze.otome@cookcountyhealth.org
InvestigatorNanda Vishakha, MD · principal_investigator, John H Stroger Hospital of Cook County, IL
All locations (1)
John H. Stroger Hospital of Cook CountyRecruiting
Chicago, Illinois, United States
Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU · TrialPath