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

NCT06252883 | Recruiting

• 1 other identifier: Pending
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (5)

• Assess other contributing factors to parental stress such as anxiety. (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 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.

• 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 Arms (2)

GROUP A (intervention group)

EXPERIMENTAL

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

Group B (control group)

NO INTERVENTION

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 OTHER

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.

Also known as: Doximity app on iPad will be used for the video call.

GROUP A (intervention group)

Eligibility Criteria

• Age: 7 Days - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Newborns with 7 days or more of NICU stay

You may not qualify if:

• intrauterine drug exposure
• major critical congenital cardiac anomaly
• major neurologic anomaly
• chromosomal disorder.

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (5)

• Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

  PMID: 8506163 RESULT

• Greene MM, Rossman B, Patra K, Kratovil AL, Janes JE, Meier PP. Depression, anxiety, and perinatal-specific posttraumatic distress in mothers of very low birth weight infants in the neonatal intensive care unit. J Dev Behav Pediatr. 2015 Jun;36(5):362-70. doi: 10.1097/DBP.0000000000000174.

  PMID: 26039191 RESULT

• Ionio C, Mascheroni E, Colombo C, Castoldi F, Lista G. Stress and feelings in mothers and fathers in NICU: identifying risk factors for early interventions. Prim Health Care Res Dev. 2019 Jun 7;20:e81. doi: 10.1017/S1463423619000021.

  PMID: 32799977 RESULT

• Okito O, Yui Y, Wallace L, Knapp K, Streisand R, Tully C, Fratantoni K, Soghier L. Parental resilience and psychological distress in the neonatal intensive care unit. J Perinatol. 2022 Nov;42(11):1504-1511. doi: 10.1038/s41372-022-01478-3. Epub 2022 Aug 4.

  PMID: 35927487 RESULT

• Gibson R, Kilcullen M. The Impact of Web-Cameras on Parent-Infant Attachment in the Neonatal Intensive Care Unit. J Pediatr Nurs. 2020 May-Jun;52:e77-e83. doi: 10.1016/j.pedn.2020.01.009. Epub 2020 Feb 1.

  PMID: 32014335 RESULT

Related Links

• Preterm babies and survival statistics.
• In 2021, 1 in 10 babies (10.5% of live births) was born preterm in the United States.
• Special care nursery admissions
• Neuroprotective core measure 2: Partnering with families - exploratory study on web-camera viewing of hospitalized infants and the effect on parental stress, anxiety, and bonding
• Parents using live streaming video cameras to view infants in a regional NICU: Impacts upon bonding, anxiety and stress

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nanda Vishakha, MD

  John H Stroger Hospital of Cook County, IL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nanda Vishakha, MD

CONTACT

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

Ugoeze Otome, MD

CONTACT

ugoeze.otome@cookcountyhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Group A (intervention group) will receive a bedside video call 2-3 days a week in addition to the daily NICU phone updates and/or bedside updates using the NICU iPad w/ "Doximity" app. This permits a link to be sent to the parent to call at a given time if the parent desires or the provider can call directly to the parent at the planned time. Parents will be shown their infant, allowed for direct talk to their baby and then updated on the baby's status and plans by the NICU team and answer any question or concern the parent may have. The device will be outside the incubator and the parents will be shown their infant through the open incubator window, so they can interact with their baby. Group B (control group) will receive the daily phone and/or bedside updates done routinely in our NICU already without the intervention.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 12, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)