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Clinical Trials/NCT06252883
NCT06252883
Recruiting
Not Applicable

Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.

Cook County Health1 site in 1 country70 target enrollmentJune 1, 2024
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Cook County Health
Enrollment
70
Locations
1
Primary Endpoint
Change in the stress level of parents of infants admitted to NICU more than 7 days.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this randomized prospective interventional study is to determine if serial bedside video calls w/audio feature to NICU parents in addition to the routine phone and/or bedside updates can reduce parental stress level. The main question it aims to answer is if the impact of audio-visual calls to nicu parents can improve parent-infant relationship in the form of reduced parental anxiety/stress level.

Participants will be parents of infants admitted to NICU for more than seven (7) days.

Parents in Group A will receive serial video call communication, 2-3 days a week in addition to the daily phone and/or bedside updates.

Parents in Group B will receive daily phone and/or bedside updates per our NICU routine.

Parents will complete a series of questionnaires (PSS-NICU, STAI Y-1 & 2 and MSPSS) at 3 designated periods during an 8-week time frame.

Researchers will compare Group A (intervention group) and Group B (control group) to see if there is any difference in the stress levels in relation to the intervention (serial video calls) at the end of the study time frame.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cook County Health
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in the stress level of parents of infants admitted to NICU more than 7 days.

Time Frame: 8 weeks after infant's enrollment or till infant is discharged, whichever comes first.

Statistical analysis of the questionnaire evaluating stress (PSS-NICU) at the 3 points of assessments during the study will be done and compared between the two groups for effect/impact of the intervention. 26 questions are rated on a 5 -point Likert scale to measure parental stress in 3 sub-areas of the questionnaire: Infant's appearance and behavior, Sights and sounds and Parental role alteration. Each scenario described is rated on a scale of 1("Not at all stressful") to 5 ("Extremely stressful") and the total score is then averaged to obtain the final score rated as 1 to 5 with higher scores indicative of high stress level.

Secondary Outcomes

  • Assess other contributing factors to parental stress such as perceived support system. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
  • Assess other contributing factors to anxiety such as change in the infant's clinical condition (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
  • Parental anxiety state at discharge time (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
  • Assess other contributing factors to parental stress such as anxiety. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
  • Assess other contributing factors to anxiety such as parental demographic factors and socioeconomic status. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)

Study Sites (1)

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