Recruiting

Observational Study

Sponsor:

Cook County Health

Code:

NCT06252883

Conditions

Stress

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Serial bedside video call communication

Study Details

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.

Conditions

Stress

Study ID

NCT06252883

Start date

Jun 1, 2024

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Nanda Vishakha, MD

312-864-6000vishakha.nanda@cookcountyhhs.org

Ugoeze Otome, MD

ugoeze.otome@cookcountyhealth.org

Locations

John H. Stroger Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Vishakha Nanda, MD

vishakha.nanda@cookcountyhhs.org

More Information

Sponsor

Cook County Health

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Parental stress
  • Anxiety
  • NICU
  • PSS-NICU
  • STAI-Y

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cook County Health on 2026-07-13.