Clinical trial NCT06316193: The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.
Official title: The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Experience, Life
Stress
Depression, Postpartum
Support, Family
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital, and health workers of the O.U. of Neonatal Pathology.

For both the qualitative and quantitative studies, it is planned to enroll at least 15 infants and their parents; at least 10 health workers who participated in the diary compilation. The study is monocentric, only the U.O. of Neonatal Pathology is involved in the study.

Brief summary: The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population:

* Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital.
* Health workers of the O.U. of Neonatal Pathology.


Eligibility criteria: Inclusion Criteria:

for the parents:

* signed informed consent;
* parents of premature infant with gestational age less than or equal to 35 gestational weeks and with birth weight less than or equal to 2kg.

for healthcare providers:

* healthcare personnel from the O.U. of Neonatal Pathology;
* signed informed consent.

Exclusion Criteria:

for parents:

* non-understanding or inability to express themselves in Italian language;
* parent of premature infant with gestational age greater than 35 gestational weeks and with birth weight greater than 2kg
* unsigned informed consent.

for health workers:

* healthcare personnel not working in the O.U. of Neonatal Pathology;
* unsigned informed consen

Primary outcomes:
measure: The objective of the qualitative phase is to provide a description of the experience of the parents of infants admitted to Neonatal Pathology and the healthcare personnel who participated in the compilation of the diary.
timeFrame: Data collection will take place between April 15, 2024 and April 15, 2025.
Secondary outcomes:
measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The instruments will be administered by one of the appropriately trained nurses.
timeFrame: Data collection will take place between April 15, 2024 and April 15, 2025.
measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Stressor Scale (PSS).
timeFrame: Data collection will take place between April 15, 2024 and April 15, 2025.
measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Data collection will take place between April 15, 2024 and April 15, 2025.
measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The Nurse Parental Support Tool (NPST).
timeFrame: Data collection will take place between April 15, 2024 and April 15, 2025.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
References: