Trial · NCT07877792
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU) | T2: approximately 5 ± 1 days before discharge from the NICU | Parental stress will be assessed using the Parental Stressor Scale-NICU (PSS-NICU). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2. |
| Primary | Parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST) | T2: approximately 5 ± 1 days before discharge from the NICU | Parental involvement in the care of the newborn will be assessed using the Nurse Parent Support Tool (NPST). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2. |
| Secondary | Perception of NICU structure and organization in mothers and partners, assessed in terms of stress and involvement | T2: approximately 5 ± 1 days before discharge from the NICU | Comparison of stress and involvement scores between mothers and partners of newborns admitted to Open Space versus Single Family Room NICUs at T2. |
| Secondary | Perceived stress among healthcare professionals measured by the Stress-Related Vulnerability Scale (SVS) | Once, at the end of the morning shift or 12-hour daily shift | Comparison of perceived stress among healthcare professionals working in Open Space versus Single Family Room NICUs, measured using the Stress-Related Vulnerability Scale (SVS). |
| Secondary | Change in parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU) from T1 to T2 | From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2) | Comparison of the change in PSS-NICU scores from T1 to T2 among parents of newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Change in parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST) from T1 to T2 | From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2) | Comparison of the change in NPST scores from T1 to T2 among parents of newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Healthcare professionals' professional and work characteristics | At study enrollment | Comparison of healthcare professionals in Open Space versus Single Family Room NICUs according to educational qualification, professional training, professional experience, weekly working hours, work schedule, and number of patients cared for. |
| Secondary | Parents' demographic characteristics | At study enrollment | Comparison of parents in Open Space versus Single Family Room NICUs according to age, sex, nationality, geographical origin, educational level, employment status, and number of children. |
| Secondary | Healthcare professionals' demographic characteristics | At study enrollment | Comparison of healthcare professionals in Open Space versus Single Family Room NICUs according to age, sex, geographical origin, educational level, professional training, professional experience, and number of children. |
| Secondary | Gestational age | At birth and approximately 5 ± 1 days before discharge (T2) | Comparison of gestational age at birth between newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Birth weight | At birth and approximately 5 ± 1 days before discharge (T2) | Comparison of birth weight between newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Clinical conditions of newborns | At T1 (15 ± 1 days after birth) and T2 (5 ± 1 days before discharge) | Comparison of the clinical conditions of newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Change in parents' satisfaction with the NICU experience from T1 to T2 | From T1 (beginning of NICU hospitalization) to T2 (before discharge) | Comparison of parents' satisfaction with the NICU experience at the beginning of hospitalization (T1) and before discharge (T2) among parents of newborns admitted to Open Space versus Single Family Room NICUs. |
| Secondary | Agreement of healthcare professionals' opinions regarding NICU structure | Once during the study, at the end of the morning shift or the 12-hour daily shift. | Assessment of agreement among healthcare professionals regarding NICU furniture, organization of spaces, devices in use, and services. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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