The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.

NCT06316193 | Completed

• 1 other identifier: DiaPaNeo
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Experience, Life; Stress; Depression, Postpartum; Support, Family

Outcome Measures

Primary Outcomes (1)

• 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.

  The diary is the tool through which the experiences of the parents of infants and included in the study and the healthcare personnel who decide to participate will be collected and analyzed. It is given to the parents in the first few days of the infant's stay, subject to the parents' written consent, accompanied by a brief letter of introduction to the diary itself, written by the nurses on the ward. This tool has been part of current clinical practice since January 2023.The diary consists of an A5-sized notebook with ruled sheets. The pages of the diary are blank, with no rigid structure,so that the parents are free to write his or her own thoughts.

  Data collection will take place between April 15, 2024 and April 15, 2025.

Secondary Outcomes (4)

• 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.

  Data collection will take place between April 15, 2024 and April 15, 2025.

• 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).

  Data collection will take place between April 15, 2024 and April 15, 2025.

• 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).

  Data collection will take place between April 15, 2024 and April 15, 2025.

• 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).

  Data collection will take place between April 15, 2024 and April 15, 2025.

Interventions

Diary OTHER

The diary is the tool through which the experiences and experiences of the parents of infants admitted to Neonatal Pathology and included in the study and the health care personnel who decide to participate will be collected and analyzed. This tool is given to the parents of infants included in the study in the first few days of the infant's stay (by the third day after admission), subject to the parents' written consent, accompanied by a brief letter of introduction to the diary itself, written by the nurses on the ward. This tool has been part of current clinical practice since January 2023.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, Principal Investigator

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 18, 2024
• Study Start: April 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: March 31, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)