Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU
ConditionStress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-60
SponsorCook County Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
intrauterine drug exposure
major critical congenital cardiac anomaly
major neurologic anomaly
chromosomal disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Serial bedside video call communication
Other interventionBedside video call with audio features, given to NICU parent/guardian 2-3 days a week for an 8-week period or till infant is discharged, whichever comes first.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: GROUP A (intervention group)Experimental treatment 1 intervention
Group B: Group B (control group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in the stress level of parents of infants admitted to NICU more than 7 days.
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.
Time frame
8 weeks after infant's enrollment or till infant is discharged, whichever comes first.Secondary outcomes
1
Assess other contributing factors to parental stress such as anxiety. (Exploratory)
Statistical analysis of the State - Trait-Anxiety-Inventory Form Y-1 questionnaire at Assessment 1 and Assessment 3 will be done and compared between the two groups for effect/impact on parental stress as measured by the parental stressor Scale- Neonatal Intensive Care unit questionnaire. 20 questions are rated on a 4-point scale with a total score range of a minimum score 20 to a maximum score 80. Higher scores indicate greater anxiety level and a score greater or equal to 40 indicates moderate to severe anxiety.
Time frame
From date of enrollment to date of last assessment, assessed up to 8weeks.2
Parental anxiety state at discharge time (Exploratory)
Statistical analysis of the State - Trait-Anxiety-Inventory Form Y-2 questionnaire at Assessment 3 will be done and compared between the two groups for effect/impact on parental stress as measured by the parental stressor Scale- Neonatal Intensive Care unit questionnaire. 20 questions are rated on a 4-point scale with a total score range of a minimum score 20 to a maximum score 80. Higher scores indicate greater anxiety level and a score greater or equal to 40 indicates moderate to severe anxiety.
Time frame
From date of enrollment to date of last assessment, assessed up to 8weeks.3
Assess other contributing factors to parental stress such as perceived support system. (Exploratory)
Statistical analysis of the Multidimensional Scale of Perceived Social support questionnaire at Assessment 1 and Assessment 3 will be done and compared between the two groups for effect/impact on parental stress as measured by the parental stressor Scale- Neonatal Intensive Care unit questionnaire. 12 questions are rated on a 7-point Likert scale ranging from 1 ("very strongly disagree) to 7 ("very strongly agree) so giving a total score range of minimum score 12 to a maximum score 84. The higher the total score, the higher the perceived support which is good.
Time frame
From date of enrollment to date of last assessment, assessed up to 8weeks.4
Assess other contributing factors to anxiety such as change in the infant's clinical condition (Exploratory)
Statistical analysis of the Infant clinical severity score at Assessment 1, Assessment 2 and Assessment 3 will be done and compared between the two groups for effect/impact on parental stress as measured by the parental stressor Scale- Neonatal Intensive Care unit questionnaire. Each variable is assigned a point (active diagnosis with each diagnosis 1-point, active medications with each medication 1-point, level of respiratory support (0 to 1-point) and surgery in past 7 days (0 to 1-point) and the points are combined to give a total final score. A higher final score indicates a more critically ill infant at the time of assessment.
Time frame
From date of enrollment to date of last assessment, assessed up to 8weeks.Sponsors and contacts
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Source ClinicalTrials.gov