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

NCT ID: NCT06252883

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-31

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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Serial bedside video call communication

Intervention Type: 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: OTHER

Other Intervention Names

Doximity app on iPad will be used for the video call.

Eligibility Criteria

Inclusion Criteria

• Newborns with 7 days or more of NICU stay

Exclusion Criteria

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 60 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nanda Vishakha, MD

Role: PRINCIPAL_INVESTIGATOR

John H Stroger Hospital of Cook County, IL

Locations

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nanda Vishakha, MD

Role: CONTACT

vishakha.nanda@cookcountyhhs.org

312-864-6000 ext. 4010

Ugoeze Otome, MD

Role: CONTACT

ugoeze.otome@cookcountyhealth.org

Facility Contacts

Vishakha Nanda, MD

Role: primary

vishakha.nanda@cookcountyhhs.org

References

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

Reference Type: RESULT

PMID: 8506163 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26039191 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32799977 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35927487 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32014335 (View on PubMed)

Related Links

https://www.nichd.nih.gov/about/org/od/directors_corner/prev_updates/preterm-births-Feb2022

Preterm babies and survival statistics.

https://www.marchofdimes.org/peristats/reports/united-states/prematurity-profile

In 2021, 1 in 10 babies (10.5% of live births) was born preterm in the United States.

https://www.kff.org/wp-content/uploads/sites/2/2013/01/nicu_summary_final.pdf

Special care nursery admissions

https://doi.org/10.1016/j.pedn.2020.01.009

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

https://doi.org/10.1016/j.jnn.2021.03.013

Parents using live streaming video cameras to view infants in a regional NICU: Impacts upon bonding, anxiety and stress

Other Identifiers

Pending

Identifier Type: -

Identifier Source: org_study_id