StressNCT06252883
Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU
A study testing Serial bedside video call communication in people with Stress, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 60 days
- Conditions the study is for
- Stress
- What is being tested?
- Serial bedside video call communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with 7 days or more of NICU stay
Who cannot join
- intrauterine drug exposure
- major critical congenital cardiac anomaly
- major neurologic anomaly
- chromosomal disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ugoeze Otome, MD contact
United States1 site, 1 recruiting
- Recruiting
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
Vishakha Nanda, MD, vishakha.nanda@cookcountyhhs.org
Ugoeze Otome, MD
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Serial bedside video call communication
- Keywords
- Parental stress, Anxiety, NICU, PSS-NICU, STAI-Y
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial bedside video call communicationOther
Also called Doximity app on iPad will be used for the video call.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From date of enrollment to date of last assessment, assessed up to 8weeks.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From date of enrollment to date of last assessment, assessed up to 8weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nanda Vishakha, MD, Principal investigator, John H Stroger Hospital of Cook County, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252883
- Sponsor's protocol ID
- 24-004
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163Greene 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.
PubMed 26039191Ionio 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.
PubMed 32799977Okito 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.
PubMed 35927487Gibson 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.
PubMed 32014335
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.
- ClinicalTrials.gov ID
- NCT06252883
- Acronym / sponsor ID
- 24-004
- Conditions
- Stress
- Keywords
- Parental stress, Anxiety, NICU, PSS-NICU, STAI-Y
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GROUP A (intervention group) | Experimental | Other: Serial bedside video call communicationParents 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 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). |
Who may qualify
- Ages
- 7 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with 7 days or more of NICU stay
Key exclusion criteria (4 listed)
- intrauterine drug exposure
- major critical congenital cardiac anomaly
- major neurologic anomaly
- chromosomal disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial bedside video call communicationAlso: Doximity app on iPad will be used for the video call.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 | GROUP A (intervention group) |
Primary outcome
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.
5 secondary outcomes
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.
Parental anxiety state at discharge time (Exploratory)
Time frame: 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Results publication: PubMed 26039191Greene 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.
- Results publication: PubMed 32799977Ionio 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.
- Results publication: PubMed 35927487Okito 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.
- Results publication: PubMed 32014335Gibson 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.
- Preterm babies and survival statistics.Link provided by the sponsor.
- In 2021, 1 in 10 babies (10.5% of live births) was born preterm in the United States.Link provided by the sponsor.
- Special care nursery admissionsLink provided by the sponsor.
- Neuroprotective core measure 2: Partnering with families - exploratory study on web-camera viewing of hospitalized infants and the effect on parental stress, anxiety, and bondingLink provided by the sponsor.
- Parents using live streaming video cameras to view infants in a regional NICU: Impacts upon bonding, anxiety and stressLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ugoeze Otome, MD contact
Nanda Vishakha, MD principal investigator
John H Stroger Hospital of Cook County, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial bedside video call communication in people with Stress, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanda Vishakha, MD (312-864-6000 ext. 4010, vishakha.nanda@cookcountyhhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06252883, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.