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Experience, LifeDiaPaNeoNCT06316193

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

An observational study of Experience, Life and Stress, run by IRCCS Ospedale San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Experience, Life, Stress, Depression, Postpartum
What is being tested?
Diary
How many people
15 participants
Where
1 siteItaly
Study dates
15 Apr 2024to 15 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

Other trials in Italy

About this study

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.
Being tested
Diary
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiaryOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  1. 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.

    The quantitative phase includes as data collection tools:

    • socio-demographic profile of the parents: for both parents, data will be collected on year of birth, gender, nationality, education level, occupation, family status, presence of other children, similar lived experiences, support from other figures close to the family (e.g., grandparents), distance from the hospital (km), religion, taking care of by a psychologist, previous experience of hospitalization in Neonatal Pathology. For the mother only: obstetric history;
    • socio-demographic profile of the newborn: gestational age, birth weight, twins, other pathologies present, type of delivery, Apgar score and prenatal diagnosis;
    • socio-demographic profile of the healthcare workers: year of birth, gender, occupational qualification, educational qualification, years of service in general and years of service in Neonatal Pathology.

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

  2. 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).

    Parental stress is a form of stress characterized by adverse psychological and physiological reactions resulting from attempts to adapt to the demands of parenting. This variable will be assessed in both parents with the PSS. The scale consists of 26 items that assess three dimensions related to parents' stress during their children's stay in the NICU:

    • lights and sounds (6 items): stress related to the physical environment of the NICU;
    • infant behavior and appearance (13 items): stress related to infant appearance and behavior;
    • parental role alteration (7 items): stress related to the alteration of the expected parental role.

    Parents are asked to rate each item with a score ranging from 1 to 5, to indicate how stressful the situation described by each item was for them (1 not at all stressful - 5 extremely stressful, NA not applicable if the experience was not experienced).The higher the score obtained by summing the scores attributed to the individual items, the higher the

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

  3. 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).

    Postpartum depression is one of the most common complications following childbirth. Postpartum depression also has negative effects on the child's behavioral, emotional and cognitive development. Symptoms of such depression include: mood lability, anxiety, irritability, feelings of overwhelm and obsessive worries or concerns, often related to the health, nutrition and safety of the baby. This variable will be collected only in mothers with the Edinburgh Postnatal Depression Scale (EPDS). This instrument is a self-assessment scale for detecting the onset of postpartum depression. It consists of 10 items answered on a 4-point Likert scale (0 - 3). In case the score obtained is higher than 12, the risk of postpartum depression should not be neglected and a specialist should be consulted. The tool has been validated in the Italian context. It will be administered only to mothers.

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

  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 Nurse Parental Support Tool (NPST).

    Parents' perceived support from medical/nursing staff: a successful relationship between parents and the care team includes parents' exchange of information, trust, and education about their children. Optimal parental caretaking by health care staff significantly reduces parental stress. The variable will be measured with The Nurse Parental Support Tool (NPST). This scale assesses parents' perceptions of their caregiving by the medical/nursing staff; it asks parents' perceptions, making explicit how often the health care staff helped them during their child's hospitalization. The scale consists of 21 items, multiple-choice, scored from 1 to 5 (1 almost never - 5 almost always). Adding up the scores for each item, higher scores reflect better parental assignment taken by the medical/nursing staff. The instrument has been validated in the Italian context

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start15 Apr 2024
  3. Primary completion15 Nov 2024
  4. Study completion15 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316193
Sponsor's protocol ID
DiaPaNeo
Acronym
DiaPaNeo
Status last verified
Sep 2024
First submitted
2 Mar 2024
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Experience, Life and Stress, run by IRCCS Ospedale San Raffaele at 1 site in Italy.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 31 Mar 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Data collection will take place between April 15, 2024 and April 15, 2025.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Mar 2026.

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