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.
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.
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.
- Conditions
- Experience, Life, Stress, Depression, Postpartum, Support, Family
- 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.
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)
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.
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.
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.
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.
- First posted18 Mar 2024
- Study start15 Apr 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experience, LifeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Ranzani, IRCCS Ospedale San Raffaele
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06316193
- Acronym / sponsor ID
- DiaPaNeo / DiaPaNeo
- Conditions
- Experience, Life, Stress, Depression, Postpartum, Support, Family
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 18 Mar 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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
- healthcare personnel from the O.U. of Neonatal Pathology;
- signed informed consent.
Key exclusion criteria (7 listed)
- 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.
- healthcare personnel not working in the O.U. of Neonatal Pathology;
- unsigned informed consen
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 |
|---|---|---|
| DiaryThe 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. | Other | – |
Primary outcome
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.
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.
4 secondary outcomes
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Data collection will take place between April 15, 2024 and April 15, 2025.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.