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The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.
The primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth.
Furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives:
The collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women during pregnancy and postpartum | Women during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires and focus groups | Other | Participation in the research involves completing a test battery composed of self-administered questionnaires, all validated in the Italian language. Additionally, qualitative data will be collected through semi-structured interviews (conducted in person or online, based on individual preferences) and focus groups, both lasting between 90 and 120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Levels of perinatal depression and of pregnancy-related anxiety | June 1, 2024 - December 31, 2025 |
| Anxiety | Levels of state and trait anxiety | June 1, 2024 - December 31, 2025 |
| Loneliness | Feelings of loneliness during and after pregnancy | June 1, 2024 - December 31, 2025 |
| Defense mechanisms | Nature of defense mechanisms during and after pregnancy | June 1, 2024 - December 31, 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Attachment bond | Quality of prenatal of attachment bond and in the postpartum period | June 1, 2024 - December 31, 2025 |
| Women subjective experience | Subjective experience of pregnancy and postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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We plan to recruit a sample of at least 134 patients. This sample size allows us to meet the recommendations obtained from conducting the power analysis.
The sample size calculation was performed using G*Power software (version 3.1.9.6, Faul et al., 2007).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Di Mattei, Professor | Contact | 0226435829 | dimattei.valentina@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Di Mattei, Professor | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Recruiting | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| June 1, 2024 - December 31, 2025 |
| Unmet needs of women | Unmet needs of women during the perinatal period | June 1, 2024 - December 31, 2025 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |