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

July 23, 2024 updated by: Cook County Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A (intervention group)
Parents in this group will receive bedside video call 2-3 days a week in addition to the routine NICU phone update and/or bedside update using the NICU iPad w/ "Doximity" app.
Other: Serial bedside video call communication
Bedside 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.
Other Names:
  • Doximity app on iPad will be used for the video call.
No Intervention: Group B (control group)
Parents in this group will receive the routine phone and/or bedside updates done in our NICU already without the intervention (serial video calls).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess other contributing factors to parental stress such as anxiety. (Exploratory)
Time Frame: From date of enrollment to date of last assessment, assessed up to 8weeks.

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.
From date of enrollment to date of last assessment, assessed up to 8weeks.
Parental anxiety state at discharge time (Exploratory)
Time Frame: From date of enrollment to date of last assessment, assessed up to 8weeks.

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.
From date of enrollment to date of last assessment, assessed up to 8weeks.
Assess other contributing factors to parental stress such as perceived support system. (Exploratory)
Time Frame: From date of enrollment to date of last assessment, assessed up to 8weeks.

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.
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)
Time Frame: From date of enrollment to date of last assessment, assessed up to 8weeks.

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.
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)
Time Frame: From date of enrollment to date of last assessment, assessed up to 8weeks.

Statistical analysis of the socio-demographics completed at Assessment 1 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.

A completed socio-demographic questionnaire will be reviewed to determine if factors such as parent gender, level of education, age in years, income in the form of employment, race, access to the health facility in the form of transportation are contributory to stress as measured by the parental stressor Scale- Neonatal Intensive Care unit questionnaire.
From date of enrollment to date of last assessment, assessed up to 8weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Investigators

  • Principal Investigator: Nanda Vishakha, MD, John H Stroger Hospital of Cook County, IL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pending (Clinical Research Information Service)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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